Small-Cell Lung CancerPhase 1/2NCT04471727
A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)
A Phase 1/2 study testing Gocatamig, Atezolizumab and Ifinatamab Deruxtecan (I-DXd) in people with Small-Cell Lung Cancer and Neuroendocrine Carcinoma, run by Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 11 sites in United States.
Trial summary
This study will investigate the maximum tolerated dose, the recommended dose for expansion (RDE), safety, efficacy, and pharmacokinetics of gocatamig alone, gocatamig with Atezolizumab and gocatamig with I-DXd in participants with advanced cancers associated with expression of Delta-like Canonical Notch Ligand 3… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small-Cell Lung Cancer, Neuroendocrine Carcinoma
- What is being tested?
- Gocatamig, Atezolizumab and Ifinatamab Deruxtecan (I-DXd)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 11 sitesUnited States
- Study dates
- 14 Dec 2020to 28 Jan 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Has a histologically or cytologically confirmed malignancy associated with expression of Delta-like Canonical Notch Ligand 3 (DLL3)
- Has small cell lung cancer (SCLC) which is relapsed/refractory following at least 1 prior line of systemic therapy that included platinum-based chemotherapy
- Has Neuroendocrine Prostate Cancer (NEPC; de novo or treatment-emergent) which is relapsed/refractory to standard systemic therapy
- Has high-grade neuroendocrine tumor types other than SCLC and NEPC, with at least one of the following:
- Disease that is relapsed/refractory to standard systemic therapy
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- Disease for which standard therapy does not exist
- Disease for which standard therapy is not considered appropriate by the Investigator
- Must be able to provide archival tissue sample or fresh biopsy tissue sample
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has untreated central nervous system (CNS) metastases
- Has a glioma or other primary CNS malignancy
- Has spinal cord compression or symptomatic/uncontrolled epidural disease
- Has a history of intracranial hemorrhage or spinal cord hemorrhage
- Has active neurologic paraneoplastic syndrome
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- Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (e.g., biweekly or more frequently)
- Has active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis
- Is ongoing treatment with immunosuppressive medications (including, but not limited to, systemic corticosteroids [prednisone dose >10mg per day or equivalent], cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] alpha agents) within 2 weeks prior to initiation of treatment, or anticipation of need for systemic immunosuppressive medication during study treatment (except protocol-required pre-medications)
- Has a history of clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (New York Heart Association > class II), and/or uncontrolled cardiac arrhythmia within 6 months of the first dose of study drug
- Has a history of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months
- Has active viral hepatitis, defined as hepatitis A (hepatitis A virus immunoglobulin M [IgM] positive), hepatitis B (hepatitis B virus surface antigen [HbsAg] positive), or hepatitis C (hepatitis C virus [HCV] antibody positive, confirmed by HCV ribonucleic acid). HCV with undetectable virus after treatment are eligible. Hepatitis B virus (HBV) with undetectable viral load by quantitative polymerase chain reaction (PCR) are eligible.
- Has uncontrolled infection with Human Immunodeficiency Virus (HIV)-1 or HIV-2. Well-controlled HIV are eligible.
- Has a history of allogeneic stem cell transplant or solid-organ transplant
- Has had treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
- Has a history of severe anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- Has a history of interstitial lung disease, idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT). History of radiation pneumonitis in the radiation field is permitted
- Has had treatment with other investigational drug within 3 weeks of scheduled dosing (or 5 half-lives of drug, whichever is shorter)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Colorado
Aurora, Colorado, 80045
Dana Farber Cancer Institute
Boston, Massachusetts, 02467
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Karmanos Cancer Center
Detroit, Michigan, 48201
Cedar-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Tennessee Oncology
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Providence
Portland, Oregon, 97213
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 Monotherapy and HPN328 With Atezolizumab or Ifinatamab Deruxtecan (I-DXd) in Patients With Advanced Cancers Associated With Expression of Delta-like Canonical Notch Ligand 3 (DLL3).
This study will investigate the maximum tolerated dose, the recommended dose for expansion (RDE), safety, efficacy, and pharmacokinetics of gocatamig alone, gocatamig with Atezolizumab and gocatamig with I-DXd in participants with advanced cancers associated with expression of Delta-like Canonical Notch Ligand 3 (DLL3).
- Conditions
- Small-Cell Lung Cancer, Neuroendocrine Carcinoma
- Being tested
- Gocatamig, Atezolizumab, Ifinatamab Deruxtecan (I-DXd)
- Keywords
- Lung Cancer, Small-Cell Lung Cancer, DLL3, Harpoon, TriTAC, Prostate Cancer, Neuroendocrine Tumors, High Grade Neuroendrocrine Features, Delta Like Canonical Notch Ligand 3, T-cell Engager
- Medical subject headings
- Small Cell Lung Carcinoma, Carcinoma, Neuroendocrine, Lung Neoplasms, Prostatic Neoplasms, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GocatamigBiological
Also called HPN328, MK-6070
IV infusion
AtezolizumabBiological
IV infusion
Ifinatamab Deruxtecan (I-DXd)Biological
Also called DS-7300a, MK-2400
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Gocatamig monotherapy dose escalation with 1 week dosing interval | Experimental | Participants will receive gocatamig once weekly (Q1W) via intravenous (IV) infusion during each 21-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation or the Sponsor decides to stop enrollment. Receives: Biological: Gocatamig |
| Gocatamig monotherapy dose escalation with 2 week dosing interval | Experimental | Participants will receive gocatamig via IV infusion once every 2 weeks (Q2W) of a 28-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment. Receives: Biological: Gocatamig |
| Gocatamig monotherapy dose escalation with 3 week dosing interval | Experimental | Participants will receive gocatamig via IV infusion once every 3 weeks (Q3W) of a 21-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment. Receives: Biological: Gocatamig |
| Gocatamig dose escalation with atezolizumab | Experimental | Small cell lung cancer (SCLC) participants will receive gocatamig via IV infusion Q2W during each 28-day cycle and Atezolizumab via IV infusion every 4 weeks (Q4W) on Day 1 of each 28-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment. Receives: Biological: Gocatamig; Biological: Atezolizumab |
| Gocatamig dose escalation in combination with I-DXd | Experimental | SCLC participants will receive gocatamig via IV infusion Q2W during each 42-day cycle and I-DXd via IV infusion Q3W on Day 1 and Day 22 of each 42-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment. Receives: Biological: Gocatamig; Biological: Ifinatamab Deruxtecan (I-DXd) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who experience an adverse event
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. AEs will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) version 5.0 (American Society for Transplant and Cellular Therapy (ASTCT) grading criteria for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)). The percentage of participants who experience an AE in the study will be presented.
Measured: Up to ~4 years
Percentage of participants who discontinue due to an adverse event
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. AEs will be graded according to NCI CTACAE version 5.0 (ASTCT grading criteria for CRS and ICANS). The percentage of participants who discontinue due to an AE in the study will be presented.
Measured: Up to ~4 years
Number of participants with dose limiting toxicity (DLT) following treatment with HPN328 as monotherapy or in combination with atezolizumab or I-DXd
A DLT is defined as an AE that represents a clinically significant shift from baseline and must be considered related or suspected to be related to study drug (gocatamig and/or atezolizumab or I-DXd) by the Investigator or Sponsor. AEs will be graded according to NCI CTACAE version 5.0 (ASTCT grading criteria for CRS and ICANS). The number of participants with a DLT will be presented.
Measured: Up to ~4 years
Maximum concentration (Cmax) of Gocatamig
Cmax is the maximum concentration of the drug observed in serum. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of gocatamig.
Measured: At designated time points up to ~4 years
Cmax of Atezolizumab
Cmax is the maximum concentration of the drug observed in serum. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of Atezolizumab.
Measured: At designated time points up to ~4 years
Cmax of I-DXd
Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of I-DXd.
Measured: At designated time points up to ~4 years
Time to maximum concentration (Tmax) of Gocatamig
Tmax is the amount of time that a drug is present at the maximum concentration observed in serum. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the Tmax of gocatamig.
Measured: At designated time points up to ~4 years
Tmax of atezolizumab
Tmax is the amount of time that a drug is present at the maximum concentration observed in serum. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the Tmax of atezolizumab.
Measured: At designated time points up to ~4 years
Tmax of I-DXd
Tmax is the amount of time that a drug is present at the maximum concentration observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the Tmax of I-DXd.
Measured: At designated time points up to ~4 years
Area under the concentration-time curve over the dosing interval t (AUCt) of Gocatamig
AUC is a measure of serum drug concentration and time and is estimated as the area under the plot of serum concentration against time after drug administration. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine t (AUCt) of gocatamig.
Measured: At designated time points up to ~4 years
AUCt of atezolizumab
AUC is a measure of serum drug concentration and time and is estimated as the area under the plot of serum concentration against time after drug administration. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine t (AUCt) of atezolizumab.
Measured: At designated time points up to ~4 years
AUCt of I-DXd
AUC is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine t (AUCt) of I-DXd.
Measured: At designated time points up to ~4 years
Area under the concentration-time curve extrapolated to infinity (AUCinf) of Gocatamig
AUCinf is a measure of serum drug concentration and time to infinity and is estimated as the area under the plot of serum concentration against time to infinity after drug administration. Blood samples collected at multiple timepoints post-dose will be used to determine the AUCinf of gocatamig.
Measured: At designated time points up to ~4 years
AUCinf of atezolizumab
AUCinf is a measure of serum drug concentration and time to infinity and is estimated as the area under the plot of serum concentration against time to infinity after drug administration. Blood samples collected at multiple timepoints post-dose will be used to determine the AUCinf of atezolizumab.
Measured: At designated time points up to ~4 years
AUCinf of I-DXd
AUCinf is a measure of plasma drug concentration and time to infinity and is estimated as the area under the plot of plasma concentration against time to infinity after drug administration. Blood samples collected at multiple timepoints post-dose will be used to determine the AUCinf of I-DXd.
Measured: At designated time points up to ~4 years
Terminal half-life (t1/2) of Gocatamig
t1/2 is a measure of how long it takes to clear 50% of the drug from serum after reaching Cmax. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the t1/2 of gocatamig.
Measured: At designated time points up to ~4 years
t1/2 of atezolizumab
t1/2 is a measure of how long it takes to clear 50% of the drug from serum after reaching Cmax. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the t1/2 of atezolizumab.
Measured: At designated time points up to ~4 years
t1/2 of I-DXd
t1/2 is a measure of how long it takes to clear 50% of the drug from plasma after reaching Cmax. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the t1/2 of I-DXd.
Measured: At designated time points up to ~4 years
Single dose clearance (CL) of Gocatamig
CL is the apparent total clearance of the drug from serum after oral administration. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine CL of gocatamig.
Measured: At designated time points up to ~4 years
CL of atezolizumab
CL is the apparent total clearance of the drug from serum after oral administration. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine CL of atezolizumab.
Measured: At designated time points up to ~4 years
CL of I-DXd
CL is the apparent total clearance of the drug from plasma after oral administration. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine CL of I-DXd.
Measured: At designated time points up to ~4 years
Steady state maximum concentration (Cmax,ss) of Gocatamig
Cmax,ss is the maximum concentration of the drug in serum observed in serum under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax,ss of gocatamig.
Measured: At designated time points up to ~4 years
Cmax,ss of atezolizumab
Cmax,ss is the maximum concentration of the drug observed in serum under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Css,max of atezolizumab.
Measured: At designated time points up to ~4 years
Cmax,ss of I-DXd
Cmax,ss is the maximum concentration of the drug observed in plasma under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax,ss of I-DXd.
Measured: At designated time points up to ~4 years
Steady state Ctrough (Ctrough,ss) of Gocatamig
Ctrough,ss is the lowest concentration reached by a drug in serum under steady state conditions before the next dose is administered. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Ctrough,ss of gocatamig.
Measured: At designated time points up to ~4 years
Ctrough,ss of atezolizumab
Ctrough,ss is the lowest concentration reached by a drug in serum under steady state conditions before the next dose is administered. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Ctrough,ss of atezolizumab.
Measured: At designated time points up to ~4 years
Ctrough,ss of I-DXd
Ctrough,ss is the lowest concentration reached by a drug in plasma under steady state conditions before the next dose is administered. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Ctrough,ss of I-DXd.
Measured: At designated time points up to ~4 years
Steady state time to maximum concentration (Tmax,ss) of Gocatamig
Tmax,ss is the amount of time that a drug is present at the maximum concentration observed in serum under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the Tmax,ss of gocatamig.
Measured: At designated time points up to ~4 years
Tmax,ss of atezolizumab
Tmax,ss is the amount of time that a drug is present at the maximum concentration observed in serum under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the Tmax,ss of atezolizumab.
Measured: At designated time points up to ~4 years
Tmax,ss of I-DXd
Tmax,ss is the amount of time that a drug is present at the maximum concentration observed in plasma under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the Tmax,ss of I-DXd.
Measured: At designated time points up to ~4 years
Area under the steady state concentration-time curve over dosing interval t (AUCt,ss) of Gocatamig
AUCt,ss is a measure of serum drug concentration and time and is estimated as the area under the plot of serum concentration against time after drug administration under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine AUCt,ss of gocatamig.
Measured: At designated time points up to ~4 years
AUCt,ss of atezolizumab
AUCt,ss is a measure of serum drug concentration and time and is estimated as the area under the plot of serum concentration against time after drug administration under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine AUCt,ss of atezolizumab.
Measured: At designated time points up to ~4 years
AUCt,ss of I-DXd
AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine AUCt,ss of I-DXd.
Measured: At designated time points up to ~4 years
Steady state t1/2 (t1/2,ss) of Gocatamig
t1/2,ss is a measure of how long it takes to clear 50% of the drug in serum after reaching Cmax under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the t1/2,ss of gocatamig.
Measured: At designated time points up to ~4 years
t1/2,ss of Gocatamig with atezolizumab
t1/2,ss is a measure of how long it takes to clear 50% of the drug after reaching Cmax under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the t1/2,ss of atezolizumab.
Measured: At designated time points up to ~4 years
t1/2,ss of IDXd
t1/2,ss is a measure of how long it takes to clear 50% of the drug in plasma after reaching Cmax under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the t1/2,ss of I-DXd.
Measured: At designated time points up to ~4 years
Steady state CL (CL,ss) of Gocatamig
CL,ss is the apparent total clearance of the drug from serum after administration under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine CL,ss of gocatamig.
Measured: At designated time points up to ~4 years
CL,ss of Gocatamig with atezolizumab
CL,ss is the apparent total clearance of the drug from serum after administration under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine CL,ss of atezolizumab.
Measured: At designated time points up to ~4 years
CL,ss of I-DXd
CL,ss is the apparent total clearance of the drug from plasma after administration under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine CL,ss of I-DXd.
Measured: At designated time points up to ~4 years
Steady state volume of distribution (V,ss) of Gocatamig
V,ss is defined as the volume of distribution in serum under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the V,ss of gocatamig.
Measured: At designated time points up to ~4 years
V,ss of atezolizumab
V,ss is defined as the volume of distribution in serum under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the V,ss of atezolizumab.
Measured: At designated time points up to ~4 years
V,ss of I-DXd
V,ss is defined as the volume of distribution in plasma under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the V,ss of I-DXd.
Measured: At designated time points up to ~4 years
Steady state accumulation ratio (AC) of Gocatamig
AC is the ratio of accumulation of a drug in serum under steady state conditions after repeated administration as compared to a single dose. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine AC of gocatamig.
Measured: At designated time points up to ~4 years
AC of atezolizumab
AC is the ratio of accumulation of a drug in serum under steady state conditions after repeated administration as compared to a single dose. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine AC of atezolizumab.
Measured: At designated time points up to ~4 years
AC of I-DXd
AC is the ratio of accumulation of a drug in plasma under steady state conditions after repeated administration as compared to a single dose. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine AC of I-DXd.
Measured: At designated time points up to ~4 years
Secondary outcomes (11)
Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) (Prostate cancer clinical trials working group 3 (PCWG3) for participants with neuroendocrine prostate cancer (NEPC))
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. Participants with NEPC will be evaluated using PCWG3-modified RECIST v1.1. ORR will be presented.
Measured: Up to ~4 years
Extra-cranial objective response rate (EC-ORR) based on modified RECIST v1.1
EC-ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 considering extra-cranial disease (i.e. exclusive of brain metastases). Participants with NEPC will be evaluated using PCWG3-modified RECIST v1.1 considering extra-cranial disease. EC-ORR will be presented.
Measured: Up to ~4 years
Best Overall Response (BOR)
BOR is defined as the participants' best disease response during the study given a hierarchy of objective response results CR: disappearance of all target lesions per RECIST 1.1 > PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1 > stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study > progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. > not all evaluated/non-PD (NE): persistence of one or more non-target lesions and/or (if applicable) maintenance of tumor marker level above the normal limits. Percentage of participants in each BOR category will be presented.
Measured: Up to ~4 years
Progression-free survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Participants with NEPC will be evaluated using PCWG3-modified RECIST v1.1 PFS will be presented.
Measured: Up to ~4 years
Extra-cranial progression free survival (EC-PFS)
EC-PFS is defined as the time from randomization to the first documented extra-cranial progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Participants with NEPC will be evaluated using PCWG3-modified RECIST v1.1. EC-PFS will be presented.
Measured: Up to ~4 years
Overall survival (OS)
OS is defined as the time from first dose of study drug to death due to any cause (summarized descriptively using Kaplan Meier method). OS will be presented.
Measured: Up to ~4 years
Duration of response (DOR)
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. Participants with NEPC will be evaluated using PCWG3-modified RECIST v1.1. DOR will be presented.
Measured: Up to ~4 years
Duration of extra-cranial response (EC-DOR)
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), EC-DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1 considering only extra-cranial disease (i.e., exclusive of brain metastases), PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. Participants with NEPC will be evaluated using PCWG3-modified RECIST v1.1. EC-DOR as assessed will be presented.
Measured: Up to ~4 years
Incidence of anti-drug antibodies (ADAs) against Gocatamig
Blood samples collected at designated timepoints will be used to determine the ADA response to gocatamig. The incidence of ADAs for gocatamig will be presented.
Measured: At designated time points up to ~4 years
Incidence of ADAs against atezolizumab (for combination-treatment patients)
Blood samples collected at designated timepoints will be used to determine the ADA response to atezolizumab. The incidence of ADAs for atezolizumab will be presented.
Measured: At designated time points up to ~4 years
Incidence of ADAs against I-DXd (for combination-treatment patients)
Blood samples collected at designated timepoints will be used to determine the ADA response to I-DXd. The incidence of ADAs for I-DXd will be presented.
Measured: At designated time points up to ~4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start14 Dec 2020
- Primary completion28 Jan 2028 (estimated)
- Study completion28 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471727
- Sponsor's protocol ID
- HPN328-4001
- Other IDs
- MK-6070-001, HPN328-4001
- Status last verified
- Feb 2026
- First submitted
- 6 Jul 2020
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 Monotherapy and HPN328 With Atezolizumab or Ifinatamab Deruxtecan (I-DXd) in Patients With Advanced Cancers Associated With Expression of Delta-like Canonical Notch Ligand 3 (DLL3).
- ClinicalTrials.gov ID
- NCT04471727
- Acronym / sponsor ID
- HPN328-4001
- Conditions
- Small-Cell Lung Cancer, Neuroendocrine Carcinoma
- Keywords
- Lung Cancer, Small-Cell Lung Cancer, DLL3, Harpoon, TriTAC, Prostate Cancer, Neuroendocrine Tumors, High Grade Neuroendrocrine Features
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 28 Jan 2028 (estimated)
- Study completion
- 28 Jan 2028 (estimated)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the maximum tolerated dose, the recommended dose for expansion (RDE), safety, efficacy, and pharmacokinetics of gocatamig alone, gocatamig with Atezolizumab and gocatamig with I-DXd in participants with advanced cancers associated with expression of Delta-like Canonical Notch Ligand 3 (DLL3).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Gocatamig monotherapy dose escalation with 1 week dosing interval | Experimental | Biological: GocatamigParticipants will receive gocatamig once weekly (Q1W) via intravenous (IV) infusion during each 21-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation or the Sponsor decides to stop enrollment. |
| Gocatamig monotherapy dose escalation with 2 week dosing interval | Experimental | Biological: GocatamigParticipants will receive gocatamig via IV infusion once every 2 weeks (Q2W) of a 28-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment. |
| Gocatamig monotherapy dose escalation with 3 week dosing interval | Experimental | Biological: GocatamigParticipants will receive gocatamig via IV infusion once every 3 weeks (Q3W) of a 21-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment. |
| Gocatamig dose escalation with atezolizumab | Experimental | Biological: Gocatamig, Biological: AtezolizumabSmall cell lung cancer (SCLC) participants will receive gocatamig via IV infusion Q2W during each 28-day cycle and Atezolizumab via IV infusion every 4 weeks (Q4W) on Day 1 of each 28-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment. |
| Gocatamig dose escalation in combination with I-DXd | Experimental | Biological: Gocatamig, Biological: Ifinatamab Deruxtecan (I-DXd)SCLC participants will receive gocatamig via IV infusion Q2W during each 42-day cycle and I-DXd via IV infusion Q3W on Day 1 and Day 22 of each 42-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has a histologically or cytologically confirmed malignancy associated with expression of Delta-like Canonical Notch Ligand 3 (DLL3)
- Has small cell lung cancer (SCLC) which is relapsed/refractory following at least 1 prior line of systemic therapy that included platinum-based chemotherapy
- Has Neuroendocrine Prostate Cancer (NEPC; de novo or treatment-emergent) which is relapsed/refractory to standard systemic therapy
- Has high-grade neuroendocrine tumor types other than SCLC and NEPC, with at least one of the following:
- Must be able to provide archival tissue sample or fresh biopsy tissue sample
Key exclusion criteria (18 listed)
- Has untreated central nervous system (CNS) metastases
- Has a glioma or other primary CNS malignancy
- Has spinal cord compression or symptomatic/uncontrolled epidural disease
- Has a history of intracranial hemorrhage or spinal cord hemorrhage
- Has active neurologic paraneoplastic syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GocatamigAlso: HPN328, MK-6070IV infusion | Biological | Gocatamig dose escalation in combination with I-DXd, Gocatamig dose escalation with atezolizumab, Gocatamig monotherapy dose escalation with 1 week dosing interval, Gocatamig monotherapy dose escalation with 2 week dosing interval, Gocatamig monotherapy dose escalation with 3 week dosing interval |
| AtezolizumabIV infusion | Biological | Gocatamig dose escalation with atezolizumab |
| Ifinatamab Deruxtecan (I-DXd)Also: DS-7300a, MK-2400IV infusion | Biological | Gocatamig dose escalation in combination with I-DXd |
Primary outcome
Percentage of participants who experience an adverse event
Time frame: Up to ~4 years
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. AEs will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) version 5.0 (American Society for Transplant and Cellular Therapy (ASTCT) grading criteria for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)). The percentage of participants who experience an AE in the study will be presented.
Percentage of participants who discontinue due to an adverse event
Time frame: Up to ~4 years
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. AEs will be graded according to NCI CTACAE version 5.0 (ASTCT grading criteria for CRS and ICANS). The percentage of participants who discontinue due to an AE in the study will be presented.
Number of participants with dose limiting toxicity (DLT) following treatment with HPN328 as monotherapy or in combination with atezolizumab or I-DXd
Time frame: Up to ~4 years
A DLT is defined as an AE that represents a clinically significant shift from baseline and must be considered related or suspected to be related to study drug (gocatamig and/or atezolizumab or I-DXd) by the Investigator or Sponsor. AEs will be graded according to NCI CTACAE version 5.0 (ASTCT grading criteria for CRS and ICANS). The number of participants with a DLT will be presented.
Maximum concentration (Cmax) of Gocatamig
Time frame: At designated time points up to ~4 years
Cmax is the maximum concentration of the drug observed in serum. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of gocatamig.
Cmax of Atezolizumab
Time frame: At designated time points up to ~4 years
Cmax is the maximum concentration of the drug observed in serum. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of Atezolizumab.
Cmax of I-DXd
Time frame: At designated time points up to ~4 years
Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of I-DXd.
Time to maximum concentration (Tmax) of Gocatamig
Time frame: At designated time points up to ~4 years
Tmax is the amount of time that a drug is present at the maximum concentration observed in serum. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the Tmax of gocatamig.
Tmax of atezolizumab
Time frame: At designated time points up to ~4 years
Tmax is the amount of time that a drug is present at the maximum concentration observed in serum. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the Tmax of atezolizumab.
Tmax of I-DXd
Time frame: At designated time points up to ~4 years
Tmax is the amount of time that a drug is present at the maximum concentration observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the Tmax of I-DXd.
Area under the concentration-time curve over the dosing interval t (AUCt) of Gocatamig
Time frame: At designated time points up to ~4 years
AUC is a measure of serum drug concentration and time and is estimated as the area under the plot of serum concentration against time after drug administration. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine t (AUCt) of gocatamig.
AUCt of atezolizumab
Time frame: At designated time points up to ~4 years
AUC is a measure of serum drug concentration and time and is estimated as the area under the plot of serum concentration against time after drug administration. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine t (AUCt) of atezolizumab.
AUCt of I-DXd
Time frame: At designated time points up to ~4 years
AUC is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine t (AUCt) of I-DXd.
Area under the concentration-time curve extrapolated to infinity (AUCinf) of Gocatamig
Time frame: At designated time points up to ~4 years
AUCinf is a measure of serum drug concentration and time to infinity and is estimated as the area under the plot of serum concentration against time to infinity after drug administration. Blood samples collected at multiple timepoints post-dose will be used to determine the AUCinf of gocatamig.
AUCinf of atezolizumab
Time frame: At designated time points up to ~4 years
AUCinf is a measure of serum drug concentration and time to infinity and is estimated as the area under the plot of serum concentration against time to infinity after drug administration. Blood samples collected at multiple timepoints post-dose will be used to determine the AUCinf of atezolizumab.
AUCinf of I-DXd
Time frame: At designated time points up to ~4 years
AUCinf is a measure of plasma drug concentration and time to infinity and is estimated as the area under the plot of plasma concentration against time to infinity after drug administration. Blood samples collected at multiple timepoints post-dose will be used to determine the AUCinf of I-DXd.
Terminal half-life (t1/2) of Gocatamig
Time frame: At designated time points up to ~4 years
t1/2 is a measure of how long it takes to clear 50% of the drug from serum after reaching Cmax. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the t1/2 of gocatamig.
t1/2 of atezolizumab
Time frame: At designated time points up to ~4 years
t1/2 is a measure of how long it takes to clear 50% of the drug from serum after reaching Cmax. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the t1/2 of atezolizumab.
t1/2 of I-DXd
Time frame: At designated time points up to ~4 years
t1/2 is a measure of how long it takes to clear 50% of the drug from plasma after reaching Cmax. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the t1/2 of I-DXd.
Single dose clearance (CL) of Gocatamig
Time frame: At designated time points up to ~4 years
CL is the apparent total clearance of the drug from serum after oral administration. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine CL of gocatamig.
CL of atezolizumab
Time frame: At designated time points up to ~4 years
CL is the apparent total clearance of the drug from serum after oral administration. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine CL of atezolizumab.
CL of I-DXd
Time frame: At designated time points up to ~4 years
CL is the apparent total clearance of the drug from plasma after oral administration. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine CL of I-DXd.
Steady state maximum concentration (Cmax,ss) of Gocatamig
Time frame: At designated time points up to ~4 years
Cmax,ss is the maximum concentration of the drug in serum observed in serum under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax,ss of gocatamig.
Cmax,ss of atezolizumab
Time frame: At designated time points up to ~4 years
Cmax,ss is the maximum concentration of the drug observed in serum under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Css,max of atezolizumab.
Cmax,ss of I-DXd
Time frame: At designated time points up to ~4 years
Cmax,ss is the maximum concentration of the drug observed in plasma under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax,ss of I-DXd.
Steady state Ctrough (Ctrough,ss) of Gocatamig
Time frame: At designated time points up to ~4 years
Ctrough,ss is the lowest concentration reached by a drug in serum under steady state conditions before the next dose is administered. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Ctrough,ss of gocatamig.
Ctrough,ss of atezolizumab
Time frame: At designated time points up to ~4 years
Ctrough,ss is the lowest concentration reached by a drug in serum under steady state conditions before the next dose is administered. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Ctrough,ss of atezolizumab.
Ctrough,ss of I-DXd
Time frame: At designated time points up to ~4 years
Ctrough,ss is the lowest concentration reached by a drug in plasma under steady state conditions before the next dose is administered. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Ctrough,ss of I-DXd.
Steady state time to maximum concentration (Tmax,ss) of Gocatamig
Time frame: At designated time points up to ~4 years
Tmax,ss is the amount of time that a drug is present at the maximum concentration observed in serum under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the Tmax,ss of gocatamig.
Tmax,ss of atezolizumab
Time frame: At designated time points up to ~4 years
Tmax,ss is the amount of time that a drug is present at the maximum concentration observed in serum under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the Tmax,ss of atezolizumab.
Tmax,ss of I-DXd
Time frame: At designated time points up to ~4 years
Tmax,ss is the amount of time that a drug is present at the maximum concentration observed in plasma under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the Tmax,ss of I-DXd.
Area under the steady state concentration-time curve over dosing interval t (AUCt,ss) of Gocatamig
Time frame: At designated time points up to ~4 years
AUCt,ss is a measure of serum drug concentration and time and is estimated as the area under the plot of serum concentration against time after drug administration under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine AUCt,ss of gocatamig.
AUCt,ss of atezolizumab
Time frame: At designated time points up to ~4 years
AUCt,ss is a measure of serum drug concentration and time and is estimated as the area under the plot of serum concentration against time after drug administration under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine AUCt,ss of atezolizumab.
AUCt,ss of I-DXd
Time frame: At designated time points up to ~4 years
AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine AUCt,ss of I-DXd.
Steady state t1/2 (t1/2,ss) of Gocatamig
Time frame: At designated time points up to ~4 years
t1/2,ss is a measure of how long it takes to clear 50% of the drug in serum after reaching Cmax under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the t1/2,ss of gocatamig.
t1/2,ss of Gocatamig with atezolizumab
Time frame: At designated time points up to ~4 years
t1/2,ss is a measure of how long it takes to clear 50% of the drug after reaching Cmax under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the t1/2,ss of atezolizumab.
t1/2,ss of IDXd
Time frame: At designated time points up to ~4 years
t1/2,ss is a measure of how long it takes to clear 50% of the drug in plasma after reaching Cmax under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the t1/2,ss of I-DXd.
Steady state CL (CL,ss) of Gocatamig
Time frame: At designated time points up to ~4 years
CL,ss is the apparent total clearance of the drug from serum after administration under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine CL,ss of gocatamig.
CL,ss of Gocatamig with atezolizumab
Time frame: At designated time points up to ~4 years
CL,ss is the apparent total clearance of the drug from serum after administration under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine CL,ss of atezolizumab.
CL,ss of I-DXd
Time frame: At designated time points up to ~4 years
CL,ss is the apparent total clearance of the drug from plasma after administration under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine CL,ss of I-DXd.
Steady state volume of distribution (V,ss) of Gocatamig
Time frame: At designated time points up to ~4 years
V,ss is defined as the volume of distribution in serum under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the V,ss of gocatamig.
V,ss of atezolizumab
Time frame: At designated time points up to ~4 years
V,ss is defined as the volume of distribution in serum under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the V,ss of atezolizumab.
V,ss of I-DXd
Time frame: At designated time points up to ~4 years
V,ss is defined as the volume of distribution in plasma under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the V,ss of I-DXd.
Steady state accumulation ratio (AC) of Gocatamig
Time frame: At designated time points up to ~4 years
AC is the ratio of accumulation of a drug in serum under steady state conditions after repeated administration as compared to a single dose. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine AC of gocatamig.
AC of atezolizumab
Time frame: At designated time points up to ~4 years
AC is the ratio of accumulation of a drug in serum under steady state conditions after repeated administration as compared to a single dose. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine AC of atezolizumab.
AC of I-DXd
Time frame: At designated time points up to ~4 years
AC is the ratio of accumulation of a drug in plasma under steady state conditions after repeated administration as compared to a single dose. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine AC of I-DXd.
11 secondary outcomes
Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) (Prostate cancer clinical trials working group 3 (PCWG3) for participants with neuroendocrine prostate cancer (NEPC))
Time frame: Up to ~4 years
Extra-cranial objective response rate (EC-ORR) based on modified RECIST v1.1
Time frame: Up to ~4 years
Best Overall Response (BOR)
Time frame: Up to ~4 years
Progression-free survival (PFS)
Time frame: Up to ~4 years
Extra-cranial progression free survival (EC-PFS)
Time frame: Up to ~4 years
Overall survival (OS)
Time frame: Up to ~4 years
Duration of response (DOR)
Time frame: Up to ~4 years
Duration of extra-cranial response (EC-DOR)
Time frame: Up to ~4 years
Incidence of anti-drug antibodies (ADAs) against Gocatamig
Time frame: At designated time points up to ~4 years
Incidence of ADAs against atezolizumab (for combination-treatment patients)
Time frame: At designated time points up to ~4 years
Incidence of ADAs against I-DXd (for combination-treatment patients)
Time frame: At designated time points up to ~4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gocatamig, Atezolizumab and Ifinatamab Deruxtecan (I-DXd) in people with Small-Cell Lung Cancer and Neuroendocrine Carcinoma, run by Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who experience an adverse event (time frame: Up to ~4 years). The study lists 45 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.