Small Cell Lung CancerPhase 1/2NCT06780137
A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)
A Phase 1/2 study testing Gocatamig, Ifinatamab Deruxtecan (I-DXd) and Durvalumab in people with Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 48 sites in 12 countries.
Trial summary
Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Gocatamig, Ifinatamab Deruxtecan (I-DXd) and Durvalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 48 sitesin 12 countries
- Study dates
- 27 Feb 2025to 15 Feb 2029
- Phase
- Phase 1/2
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
- Has histologically or cytologically confirmed SCLC that is extensive stage (defined as Stage IV (T any, N any, M1a/b/c) following at least 1 prior line of systemic therapy that included platinum-based chemotherapy
- Must be able to provide archival tumor tissue sample or fresh biopsy tissue sample
- Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
Who cannot join
- Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure
- Any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use except for a history of radiation pneumonitis that did not require steroids
- Current history of ILD or clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Active or history of immune deficiency with the exception of HIV-infected participants with well controlled HIV on ART
- History within 6 months before the first dose of study intervention of coronary/peripheral artery bypass graft and/or any coronary/peripheral angioplasty or clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (CHF) (New York Heart Association > class II), and/or uncontrolled cardiac arrhythmia
Show all 23Show fewer
- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention
- Active clinically significant infection requiring systemic therapy
- History of allogeneic tissue/solid organ transplant
- History of leptomeningeal disease
- Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- Receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of chronic immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- Untreated or symptomatic brain metastases
- Active viral hepatitis, defined as hepatitis A (hepatitis A virus immunoglobulin M [IgM] positive in the setting of associated signs/symptoms), hepatitis B (hepatitis B virus surface antigen [HbsAg] positive and/or detectable hepatitis B virus [HBV] deoxyribonucleic acid [DNA]), or hepatitis C (hepatitis C virus [HCV] antibody positive and detectable HCV ribonucleic acid). Participants with HBV with undetectable viral load after treatment are eligible. Participants with HCV with undetectable virus after treatment are eligible.
- Part 1 only: Radiation therapy to the lung >30 Gy within 6 months before the start of study intervention
- Part 1 only: Abdominal radiation within 4 weeks before start of study intervention
- Part 1 only: Anticancer hormonal treatment (except luteinizing hormone-releasing hormone [LHRH]) within 2 weeks before start of study intervention
- Part 1 only: Systemic anticancer therapy (except antibody-based anticancer therapy) or investigational agents within 3 weeks or 5 half-lives, whichever is longer
- Part 1 only: Antibody-based cancer therapy within 3 weeks before start of study intervention
- Part 1 only: Chloroquine/hydroxychloroquine within 2 weeks before start of study intervention
- Part 1 only: Clinically significant corneal disease
- Part 1 only: Has other uncontrolled or significant protocol-specified cardiovascular disease
Trial locations and contacts
48 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
48 sites in 12 countries
United States9 sites, 9 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus ( Site 1110)
Aurora, Colorado, 80045
Study Coordinator, 303-724-6268
- Recruiting
Dana Farber Cancer Institute ( Site 1105)
Boston, Massachusetts, 02215
Study Coordinator, 617-632-6049
- Recruiting
Roswell Park Cancer Institute ( Site 1107)
Buffalo, New York, 14263
Study Coordinator, 716-845-3167
- Recruiting
University of Chicago ( Site 1108)
Chicago, Illinois, 60637
Study Coordinator, 773-702-6149
- Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)
Hackensack, New Jersey, 07601
Study Coordinator, 551-996-5863
- Recruiting
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)
Miami, Florida, 33136
Study Coordinator, 305-243-1754
- Recruiting
Medical College of Wisconsin ( Site 1112)
Milwaukee, Wisconsin, 53226
Study Coordinator, 414-805-8900
- Recruiting
Sarah Cannon Research Institute ( Site 7001)
Nashville, Tennessee, 37203
Study Coordinator, 844-482-4812
- Recruiting
Providence Portland Medical Center ( Site 1101)
Portland, Oregon, 97213
Study Coordinator, 503-215-5696
China7 sites, 7 recruiting
- Recruiting
Beijing Cancer Hospital ( Site 5401)
Beijing, Beijing Municipality, 100142
Study Coordinator, (010) 88121122
- Recruiting
West China Hospital of Sichuan University ( Site 5416)
Chengdu, Sichuan, 610041
Study Coordinator, 02885423237
- Recruiting
Fujian Cancer Hospital ( Site 5413)
Fuzhou, Fujian, 350014
Study Coordinator, 0591-62002053
- Recruiting
The First Affiliated Hospital, Zhejiang University ( Site 5404)
Hangzhou, Zhejiang, 310000
Study Coordinator, 13675843246
- Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Site 5403)
Nanjing, Jiangsu, 210008
Study Coordinator, 025-83106666
- Recruiting
Shanghai Chest Hospital ( Site 5400)
Shanghai, Shanghai Municipality, 200030
Study Coordinator, 021-22200000
- Recruiting
Shanghai Pulmonary Hospital ( Site 5405)
Shanghai, Shanghai Municipality, 200433
Study Coordinator, 15801709047
Spain7 sites, 7 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron ( Site 3311)
Barcelona, 08035
Study Coordinator, +34934894158
- Recruiting
HOSPITAL CLÍNIC DE BARCELONA ( Site 3310)
Eixample, Barcelona, 08036
Study Coordinator, +34932275402
- Recruiting
Institut Català d'Oncologia - L'Hospitalet ( Site 3317)
L'Hospitalet de Llobregat, Barcelona, 08907
Study Coordinator, +34932607744
- Recruiting
Hospital Clinico San Carlos... ( Site 3316)
Madrid, Madrid, Comunidad de, 28040
Study Coordinator, 34913303000x484804
- Recruiting
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315)
Madrid, 28040
Study Coordinator, +34915504800ext2805
- Recruiting
Hospital Universitario HM Sanchinarro ( Site 3313)
Madrid, 28050
Study Coordinator, +34917567984
- Recruiting
Hospital Universitario Virgen de la Victoria ( Site 3312)
Málaga, 29010
Study Coordinator, +34671594566
Israel4 sites, 3 recruiting
- Active, not recruiting
Rambam Health Care Campus ( Site 3202)
Haifa, 3109601
- Recruiting
Shaare Zedek Medical Center ( Site 3200)
Jerusalem, 9103102
Study Coordinator, 026555768
- Recruiting
Rabin Medical Center ( Site 3203)
Petah Tikva, 4941492
Study Coordinator, +97239378101
- Recruiting
Sheba Medical Center ( Site 3201)
Ramat Gan, 5265601
Study Coordinator, 97235304498
Japan4 sites, 4 recruiting
- Recruiting
Kansai Medical University Hospital ( Site 5004)
Hirakata, Osaka, 573-1191
Study Coordinator, +81-72-804-2808
- Recruiting
National Cancer Center Hospital East ( Site 5001)
Kashiwa, Chiba, 277-0882
Study Coordinator, +81-4-7133-1111
- Recruiting
Cancer Institute Hospital of JFCR ( Site 5002)
Koto, Tokyo, 135-8550
Study Coordinator, +81-3-3520-0111
- Recruiting
Aichi Cancer Center ( Site 5000)
Nagoya, Aichi-ken, 464-8681
Study Coordinator, +81-52-762-6111
Chile3 sites, 3 recruiting
- Recruiting
FALP ( Site 2100)
Santiago, Region M. de Santiago, 7500921
Study Coordinator, +56224205098
- Recruiting
Pontificia Universidad Catolica de Chile ( Site 2102)
Santiago, Region M. de Santiago, 8330032
Study Coordinator, +5690233407
- Recruiting
Bradfordhill ( Site 2101)
Santiago, Region M. de Santiago, 8420383
Study Coordinator, +56229490970
South Korea3 sites, 3 recruiting
- Recruiting
Seoul National University Hospital ( Site 5100)
Seoul, 03080
Study Coordinator, +82220723559
- Recruiting
Severance Hospital, Yonsei University Health System ( Site 5102)
Seoul, 03722
Study Coordinator, +82215991004
- Recruiting
Samsung Medical Center ( Site 5101)
Seoul, 06351
Study Coordinator, +82234101795
United Kingdom3 sites
- Active, not recruiting
The Clatterbridge Cancer Centre ( Site 3903)
Liverpool, L7 8YA
- Active, not recruiting
National Institute for Health Research UCLH Clinical Research Facility ( Site 3902)
London, London, City of, W1T 7HA
- Active, not recruiting
The Christie NHS Foundation Trust ( Site 3901)
Manchester, M20 4BX
Argentina2 sites, 2 recruiting
- Recruiting
Hospital Universitario Austral ( Site 2204)
Pilar, Buenos Aires, B1629WWA
Study Coordinator, +5402304482000
- Recruiting
Sanatorio Parque ( Site 2203)
Rosario, Santa Fe Province, S2000DSV
Study Coordinator, +5493416955611
Australia2 sites, 2 recruiting
- Recruiting
Monash Health ( Site 5301)
Clayton, Victoria, 3168
Study Coordinator, +61417607416
- Recruiting
Princess Alexandra Hospital ( Site 5300)
Woolloongabba, Queensland, 4102
Study Coordinator, +61731766577
Taiwan2 sites, 2 recruiting
- Recruiting
National Cheng Kung University Hospital ( Site 5202)
Tainan, 704
Study Coordinator, +88662353535
- Recruiting
Taipei Medical University Hospital ( Site 5201)
Taipei, 11030
Study Coordinator, +886227372181
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Hacettepe Universite Hastaneleri ( Site 3410)
Ankara, 06230
Study Coordinator, +903123055000
- Recruiting
Ankara Bilkent Sehir Hastanesi ( Site 3412)
Ankara, 06800
Study Coordinator, +90312 552 6084
About this study
Official title: A Phase 1b/2 Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer
Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Ifinatamab deruxtecan (also known as I-DXd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. Durvalumab is a different type of immunotherapy that also destroys cancer cells. Researchers want to know if giving gocatamig, I-DXd, and gocatamig with I-DXd or durvalumab can treat SCLC that did not respond or stopped responding to a prior treatment.
The goals of this study are to learn:
- If gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab are safe and well tolerated
- If people who receive gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab have their SCLC get smaller or go away
Read the detailed description
This study will consist of two parts. Part 1 will assess the safety, tolerability, and efficacy of gocatamig and I-DXd at doses determined in study MK-6070-001 (NCT: NCT04471727). Part 2 will assess the safety and tolerability of gocatamig in participants in Japan and China. Part 3 will assess the safety, tolerability, and efficacy of gocatamig with durvalumab.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Gocatamig, Ifinatamab Deruxtecan (I-DXd), Durvalumab
- Medical subject headings
- Small Cell Lung Carcinoma
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
Ifinatamab Deruxtecan (I-DXd)Biological
Also called DS-7300a, MK-2400
IV infusion
DurvalumabBiological
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Arm 1: Gocatamig and I-DXd | Experimental | Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met. Receives: Biological: Gocatamig; Biological: Ifinatamab Deruxtecan (I-DXd) |
| Part 1 Arm 2: Gocatamig and I-DXd | Experimental | Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met. Receives: Biological: Gocatamig; Biological: Ifinatamab Deruxtecan (I-DXd) |
| Part 1 Arm 3a: I-DXd Monotherapy | Experimental | Participants will receive I-DXd until documented disease progression or discontinuation criteria are met. Receives: Biological: Ifinatamab Deruxtecan (I-DXd) |
| Part 1 Arm 3b: Gocatamig and I-DXd | Experimental | Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met. Receives: Biological: Gocatamig; Biological: Ifinatamab Deruxtecan (I-DXd) |
| Part 2 Arm 4: Gocatamig Monotherapy in Japan | Experimental | Participants in Japan will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met. Receives: Biological: Gocatamig |
| Part 2 Arm 5: Gocatamig Monotherapy in China | Experimental | Participants in China will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met. Receives: Biological: Gocatamig |
| Part 2 Arm 6: Gocatamig | Experimental | Participants will receive gocatamig at a determined dose until documented disease progression or discontinuation criteria are met. Receives: Biological: Gocatamig |
| Part 3 Arm 7: Gocatamig and Durvalumab | Experimental | Participants will receive gocatamig and durvalumab at a determined dose until documented disease progression or discontinuation criteria are met. Receives: Biological: Gocatamig; Biological: Durvalumab |
| Part 2 Arm 8: Gocatamig (Alternate Presentation) | Experimental | Participants will receive an alternate presentation of gocatamig at a determined dose until documented disease progression or discontinuation criteria are met. Receives: Biological: Gocatamig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE in the study will be presented.
Measured: Up to approximately 44 months
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
A DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period that meet pre-defined DTL criteria. Toxicities will be graded using National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) version 5.0, or the American Society for Transplant and Cellular Therapy (ASTCT) criteria. The number of participants who experience at least one DLT will be presented.
Measured: Up to approximately 3 weeks
Number of Participants Who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue the study intervention due to an AE in the study will be presented.
Measured: Up to approximately 44 months
Part 1: Objective Response Rate (ORR)
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 Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
Measured: Up to approximately 44 months
Secondary outcomes (49)
Part 1, Part 2 (Arm 5, Arm 6, and Arm 8), and Part 3 (Arm 7): 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 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. DOR as assessed by the investigator will be presented.
Measured: Up to approximately 44 months
Part 1, Part 2 (Arm 6 and Arm 8), and Part 3 (Arm 7): Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by 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. PFS as assessed by the investigator will be presented.
Measured: Up to approximately 44 months
Part 2 (Arm 5, Arm 6, and Arm 8) and Part 3 (Arm 7): ORR
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 Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
Measured: Up to approximately 44 months
Maximum Concentration (Cmax) of gocatamig
Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the drug gocatamig.
Measured: At designated timepoints (up to approximately 44 months)
Cmax of ifinatamab deruxtecan (I-DXd)
Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the drug I-DXd.
Measured: At designated timepoints (up to approximately 44 months)
Cmax of Anti-B7-H3 Antibody
Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the anti-B7-H3 antibody.
Measured: At designated timepoints (up to approximately 44 months)
Cmax of Deruxtecan (DXd)
Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the drug payload deruxtecan (DXd).
Measured: At designated timepoints (up to approximately 44 months)
Cmax of Durvalumab
Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of durvalumab.
Measured: At designated timepoints (up to approximately 44 months)
Time to maximum concentration (Tmax) of gocatamig
Tmax is the amount of time that a drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the drug gocatamig.
Measured: At designated timepoints (up to approximately 44 months)
Tmax of I-DXd
Tmax is the amount of time that a drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the drug I-DXd.
Measured: At designated timepoints (up to approximately 44 months)
Tmax of Anti-B7-H3 Antibody
Tmax is the amount of time that the drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the anti-B7-H3 antibody.
Measured: At designated timepoints (up to approximately 44 months)
Tmax of DXd
Tmax is the amount of time that the drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the drug payload DXd.
Measured: At designated timepoints (up to approximately 44 months)
Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of gocatamig
AUCt 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 will be collected to determine the AUCt of the drug gocatamig.
Measured: At designated timepoints (up to approximately 44 months)
AUCt of I-DXd
AUCt 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 will be collected to determine the AUCt of the drug I-DXd.
Measured: At designated timepoints (up to approximately 44 months)
AUCt of Anti-B7-H3 Antibody
AUCt 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 will be collected to determine the AUCt of the anti-B7-H3 antibody.
Measured: At designated timepoints (up to approximately 44 months)
AUCt of DXd
AUCt 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 will be collected to determine the AUCt of the drug payload Dxd.
Measured: At designated timepoints (up to approximately 44 months)
Terminal Half-Life (t1/2) of gocatamig
t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the drug gocatamig.
Measured: At designated timepoints (up to approximately 44 months)
t1/2 of I-DXd
t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the drug I-DXd.
Measured: At designated timepoints (up to approximately 44 months)
t1/2 of Anti-B7-H3 Antibody
t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the anti-B7-H3 antibody.
Measured: At designated timepoints (up to approximately 44 months)
t1/2 of DXd
t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the drug payload DXd.
Measured: At designated timepoints (up to approximately 44 months)
Steady State Maximum Concentration (Cmax,ss) of gocatamig
Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the drug gocatamig.
Measured: At designated timepoints (up to approximately 44 months)
Cmax,ss of I-DXd
Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the drug I-DXd.
Measured: At designated timepoints (up to approximately 44 months)
Cmax,ss of Anti-B7-H3 Antibody
Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the anti-B7-H3 antibody.
Measured: At designated timepoints (up to approximately 44 months)
Cmax,ss of DXd
Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the drug payload DXd.
Measured: At designated timepoints (up to approximately 44 months)
Cmax,ss of Durvalumab
Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the durvalumab.
Measured: At designated timepoints (up to approximately 44 months)
Steady State Ctrough (Ctrough,ss) of gocatamig
Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the drug gocatamig.
Measured: At designated timepoints (up to approximately 44 months)
Ctrough,ss of I-DXd
Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the drug I-DXd.
Measured: At designated timepoints (up to approximately 44 months)
Ctrough,ss of Anti-B7-H3 Antibody
Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the anti-B7-H3 antibody.
Measured: At designated timepoints (up to approximately 44 months)
Ctrough,ss of DXd
Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the drug payload DXd.
Measured: At designated timepoints (up to approximately 44 months)
Ctrough,ss of Durvalumab
Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of durvalumab.
Measured: At designated timepoints (up to approximately 44 months)
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 is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the drug gocatamig.
Measured: At designated timepoints (up to approximately 44 months)
Tmax,ss of I-DXd
Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the drug I-DXd.
Measured: At designated timepoints (up to approximately 44 months)
Tmax,ss of Anti-B7-H3 Antibody
Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the anti-B7-H3 antibody.
Measured: At designated timepoints (up to approximately 44 months)
Tmax,ss of DXd
Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the drug payload DXd.
Measured: At designated timepoints (up to approximately 44 months)
Area Under the Steady State Concentration-Time Curve Over Dosing Interval t (AUCt,ss) of gocatamig
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 measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the drug gocatamig.
Measured: At designated timepoints (up to approximately 44 months)
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 measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the drug I-DXd.
Measured: At designated timepoints (up to approximately 44 months)
AUCt,ss of Anti-B7-H3 Antibody
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 measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the anti-B7-H3 antibody.
Measured: At designated timepoints (up to approximately 44 months)
AUCt,ss of 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 measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the drug payload DXd.
Measured: At designated timepoints (up to approximately 44 months)
Steady state t1/2 (t1/2,ss) of gocatamig
t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the drug gocatamig.
Measured: At designated timepoints (up to approximately 44 months)
t1/2,ss of I-DXd
t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the drug I-DXd.
Measured: At designated timepoints (up to approximately 44 months)
t1/2,ss of Anti-B7-H3 Antibody
t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the anti-B7-H3 antibody.
Measured: At designated timepoints (up to approximately 44 months)
t1/2,ss of DXd
t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the drug payload DXd.
Measured: At designated timepoints (up to approximately 44 months)
Accumulation Ratio (AC) of gocatamig
Blood samples will be collected to determine the AC of the drug gocatamig.
Measured: At designated timepoints (up to approximately 44 months)
AC of I-DXd
Blood samples will be collected to determine the AC of the drug I-DXd.
Measured: At designated timepoints (up to approximately 44 months)
AC of Anti-B7-H3 Antibody
Blood samples will be collected to determine the AC of the anti-B7-H3 antibody.
Measured: At designated timepoints (up to approximately 44 months)
AC of DXd
Blood samples will be collected to determine the AC of the drug payload DXd.
Measured: At designated timepoints (up to approximately 44 months)
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 timepoints (up to approximately 44 months)
Incidence of ADAs Against I-DXd
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 timepoints (up to approximately 44 months)
Incidence of ADAs Against Durvalumab
Blood samples collected at designated timepoints will be used to determine the ADA response to durvalumab. The incidence of ADAs for durvalumab will be presented.
Measured: At designated timepoints (up to approximately 44 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start27 Feb 2025
- Primary completion15 Feb 2029 (estimated)
- Study completion15 Feb 2029 (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.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1 consists of four arms (gocatamig and I-DXd at different dosing intervals). Participants will be randomized to one of the four arms using an interactive response technology (IRT) system. Part 2 consists of four arms (gocatamig monotherapy in participants in Japan, gocatamig monotherapy in participants in China, and gocatamig evaluated at different dosing intervals across two additional study arms). Part 3 consists of a single arm (gocatamig and durvalumab).
- Masking
- None (open label)
- Enrolment
- 327 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- 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
- NCT06780137
- Sponsor's protocol ID
- 6070-002
- Other IDs
- 2024-517926-25-00, MK-6070-002, jRCT2031250039
- Status last verified
- Sep 2026
- First submitted
- 13 Jan 2025
- Last updated
- 6 Oct 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