Solid TumorsPhase 1NCT03708328
A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors
A Phase 1 study testing Lomvastomig in people with Solid Tumors and Metastatic Melanoma, run by Hoffmann-La Roche at 17 sites in 6 countries.
Trial summary
This is a first-in-human, open-label, multicenter, Phase I multiple-ascending dose (MAD) study of single agent lomvastomig (RO7121661), an anti PD-1 (programmed death-1) and TIM-3 (T-cell immunoglobulin and mucin domain 3) bispecific antibody, for participants with advanced and/or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Metastatic Melanoma, Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Lomvastomig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 17 sitesin 6 countries
- Study dates
- 15 Oct 2018to 9 Jul 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- General Inclusion Criteria:
- Part A: Patient must have histologically or cytologically confirmed advanced and/or metastatic solid tumor malignancies for which standard curative or palliative measures do not exist, are no longer effective, or are not acceptable to the patient
- Eastern Cooperative Oncology Group Performance Status 0-1
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- Fresh biopsies may be required
- Negative HIV, hepatitis B, or hepatitis C test result
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- Women of childbearing potential and male participants must agree to remain abstinent or use contraceptive methods as defined by the protocol
- Additional Specific Inclusion Criteria for Participants with Melanoma:
- Histologically confirmed, unresectable stage III or stage IV melanoma
- Previously treated with approved anti-programmed death-ligand 1 (PD-L1)/anti-programmed death-1 (PD-1) agents with or without approved anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) therapy and up to one additional treatment regimen
- Additional Specific Inclusion Criteria for Participants with Non-small Cell Lung Cancer (NSCLC) who Previously Received Treatment for Metastatic Disease:
- Histologically confirmed advanced NSCLC
- Previously treated with approved PD-L1/PD-1 inhibitors and platinum-based chemotherapy
- Not more than 2 prior lines of treatment for metastatic disease are allowed prior to enrolling to the study
- Participants must have experienced initial clinical benefit (stable disease or better) from most recent checkpoint inhibitor (CPI) therapy
- Tumor PD-L1 expression as determined by immunohistochemistry assay of archival tumor tissue or tissue obtained at screening
- Additional Specific Inclusion Criteria for Participants with Non-small Cell Lung Cancer (NSCLC) who Previously Did Not Receive Treatment for Metastatic Disease:
- Histologically confirmed advanced NSCLC
- Tumor PD-L1 expression as determined by immunohistochemistry assay of archival tumor tissue or tissue obtained at screening
- Additional Specific Inclusion Criteria for Participants with Small Cell Lung Cancer (SCLC):
- Histologically confirmed SCLC
- Participants may have had prior chemotherapy, radiation therapy, or declined approved therapies for SCLC
- Additional Specific Inclusion Criteria for Participants with Esophageal Squamous Cell Carcinoma (ESCC):
- Participants whose major lesion was histologically confirmed as squamous cell carcinoma or adenosquamous cell carcinoma of the esophagus
- Patients who have previously received not more than 1 prior line of treatment for metastatic disease prior to enrolling to the study
Who cannot join
- General Exclusion Criteria:
- Pregnancy, lactation, or breastfeeding
- Known hypersensitivity to any of the components of RO7121661
- Active or untreated central nervous system (CNS) metastases
- An active second malignancy
- Evidence of concomitant diseases, metabolic dysfunction, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
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- Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infection
- Treatment with oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
- Active or history of autoimmune disease or immune deficiency
- Prior treatment with adoptive cell therapies, such as CAR-T therapies
- Concurrent therapy with any other investigational drug <28 days or 5 half-lives of the drug, whichever is shorter, prior to the first RO7247669 administration
- Regular immunosuppressive therapy
- Radiotherapy within the last 4 weeks before start of study drug treatment, with the exception of limited palliative radiotherapy
- Prior treatment with a T-cell immunoglobulin and mucin domain-3 (TIM-3) inhibitor
- Additional Specific Exclusion Criteria for Participants with NSCLC who Previously Received Treatment for Metastatic Disease:
- Patients with the following mutations, rearrangements, translocations are not eligible: epidermal growth factor receptor (EGFR); anaplastic lymphoma kinase (ALK); ROS proto-oncogene 1 (ROS1), BRAFV600E, and neurotrophic receptor tyrosine kinase (NTRK)
- Additional Specific Exclusion Criteria for Participants with NSCLC who Did Not Previously Receive Treatment for Metastatic Disease:
- Prior therapy for metastatic disease
- Adjuvant anti-PD-1 or anti-PD-L1 therapy
- Additional Specific Exclusion Criteria for Participants with Small-Cell Lung Cancer (SCLC):
- Prior therapy with any immune CPIs (such as anti-PD-L1/PD-1, CTLA-4)
- Additional Specific Exclusion Criteria for Participants with Esophageal Squamous Cell Carcinoma (ESCC):
- Prior therapy with any immunomodulatory agents
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
Spain5 sites
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
Hospital Ramon y Cajal
Madrid, 28034
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, 28040
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital Clínico Universitario de Valencia
Valencia, 46010
France4 sites
Institut Bergonie
Bordeaux, 33076
Centre Leon Berard
Lyon, 69008
CHU Timone
Marseille, 13005
ICO Rene Gauducheau
Saint-Herblain, 44805
South Korea3 sites
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
United States2 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Columbia Univ Med Ctr
New York, New York, 10032
About this study
Official title: An Open Label, Multicenter, Dose Escalation and Expansion, Phase 1 Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7121661, a PD-1/TIM-3 Bispecific Antibody, in Patients With Advanced and/or Metastatic Solid Tumors
This is a first-in-human, open-label, multicenter, Phase I multiple-ascending dose (MAD) study of single agent lomvastomig (RO7121661), an anti PD-1 (programmed death-1) and TIM-3 (T-cell immunoglobulin and mucin domain 3) bispecific antibody, for participants with advanced and/or metastatic solid tumors. The study consists of 2 parts: Dose Escalation (Part A) and Expansion (Parts B1, B2, B3, B4, and B5). The Dose Escalation part will be conducted first to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) based on safety, tolerability, pharmacokinetic, and/or the pharmacodynamic profile of escalating doses of lomvastomig. The Expansion part will enroll tumor-specific cohorts to evaluate anti-tumor activity of the MTD and/or RDE of lomvastomig from Part A (Q2W) and to confirm safety and tolerability in participants with selected tumor types.
- Conditions
- Solid Tumors, Metastatic Melanoma, Non-small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC), Esophageal Squamous Cell Carcinoma (ESCC)
- Being tested
- Lomvastomig
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LomvastomigDrug
Also called RO7121661, RG7769
Lomvastomig will be administered intravenously (IV) with a flat dose on the schedule described for each study arm.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Part A: Once Every 2 Weeks (Q2W) | Experimental | Lomvastomig will be administered in treatment cycles once every 2 weeks (Q2W). Dose escalation will be carried out according to a modified continual reassessment method (mCRM) with escalation with overdose control (EWOC) design. Receives: Drug: Lomvastomig |
| Expansion Part B1: Metastatic Melanoma Cohort | Experimental | This cohort will comprise participants with checkpoint inhibitor (CPI) experienced, second line and beyond metastatic melanoma. The starting dose of lomvastomig for Expansion will be derived from the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) and the best dosing schedule determined during Dose Escalation. Receives: Drug: Lomvastomig |
| Expansion Part B2: NSCLC Cohort 1 | Experimental | This cohort will comprise participants with CPI and platinum experienced, second or third line PD-L1 positive non-small cell lung cancer (NSCLC). The starting dose of lomvastomig for Expansion will be derived from the MTD/RDE and the best dosing schedule determined during Dose Escalation. Receives: Drug: Lomvastomig |
| Expansion Part B3: NSCLC Cohort 2 | Experimental | This cohort will comprise participants with PD-L1 high, cancer immunotherapy (CIT) naïve first line NSCLC. The starting dose of lomvastomig for Expansion will be derived from the MTD/RDE and the best dosing schedule determined during Dose Escalation.
This cohort was not initiated and no participants were enrolled in it. Receives: Drug: Lomvastomig |
| Expansion Part B4: SCLC Cohort | Experimental | This cohort will comprise participants with CPI naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to, standard therapy. The starting dose of lomvastomig for Expansion will be derived from the MTD/RDE and the best dosing schedule determined during Dose Escalation. Receives: Drug: Lomvastomig |
| Expansion Part B5: ESCC Cohort | Experimental | This cohort will comprise participants with CPI-naïve esophageal squamous cell carcinoma (ESCC). The starting dose of lomvastomig for Expansion will be derived from the MTD/RDE and the best dosing schedule determined during Dose Escalation. Receives: Drug: Lomvastomig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of Participants With a Dose-Limiting Toxicity (DLT)
A DLT was defined as a clinically significant adverse event (AE) or significant laboratory abnormality: 1) occurring during DLT assessment period of 21 days; 2) considered to be related to study treatment RO7121661 by the Investigator; 3) is not attributed to disease progression or another clearly identifiable cause. Following AEs were considered DLTs: Hematological toxicities (Grade 4 neutropenia lasting >5 days, Grade ≥3 febrile neutropenia, Grade 4 thrombocytopenia lasting > 48 hours, Grade 3 thrombocytopenia associated with bleeding episodes, Grade 4 anemia, Grade ≥3 anemia with hemolysis); Non-hematological toxicity Grade ≥3 (Any Grade 3 immune-mediated AE, Grade 3 hyperbilirubinemia lasting for >48 hours/Grade 4 hyperbilirubinemia; Grade ≥3 aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations with hyperbilirubinemia of Grade ≥2, Grade 4 AST or ALT elevations, Grade ≥3 nausea, vomiting, or diarrhea, Grade ≥3 non-hematological laboratory abnormality.
Measured: From Cycle 1 Day 1 to Cycle 2 Day 7 (Cycle length= 14 days)
Part A: Number of Participants With at Least One AE by Highest Severity, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
AE=any untoward medical occurrence in a participant administered a pharmaceutical product \& which does not necessarily have a causal relationship with treatment \& can therefore be any unfavorable \& unintended sign (including abnormal laboratory values/abnormal clinical test results), symptoms/disease temporally associated with the use of pharmaceutical product, whether or not considered related to pharmaceutical product. Severity of AEs was graded as: Grade 1=Mild, asymptomatic/mild symptoms, clinical/diagnostic observations only, or intervention not indicated; Grade 2=Moderate, minimal, local/non-invasive intervention indicated, or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe/medically significant but not immediately life-threatening, hospitalization/prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4= Life-threatening consequences, urgent intervention indicated; Grade 5=Death related to AE.
Measured: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months)
Part B: Objective Response Rate (ORR) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
ORR was defined as the percentage of participants with an objective tumor response of complete response (CR) or partial response (PR) as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD.
Measured: Cycle 1 Day 1 then every 8 weeks for the first year; every 12 weeks thereafter until disease progression or treatment discontinuation (whichever occurs last), initiation of a new line of therapy or death (Up to 43.3 months) (Cycle length= 14 days)
Part B: Disease Control Rate (DCR) as Determined by Investigator Using RECIST v1.1
DCR was defined as the percentage of participants with an objective tumor response of CR, PR or stable disease (SD) as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression (PD). PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Measured: Cycle 1 Day 1 then every 8 weeks for the first year; every 12 weeks thereafter until disease progression or treatment discontinuation (whichever occurs last), initiation of a new line of therapy or death (Up to 43.3 months) (Cycle length= 14 days)
Part B: Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1
DOR was calculated for participants who had a best confirmed overall response (OR) of CR/PR. DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death (within 30 days from last treatment) from any cause, whichever occurs first as determined by investigator assessment using RECIST v1.1. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Data for participants without PD or death as of the data cut-off date were censored at the time of the last tumor assessment.
Measured: From first occurrence of documented OR up to disease progression or death (Up to 43.3 months) (Cycle length = 14 days)
Part B: Progression Free Survival (PFS) as Determined by Investigator Using RECIST v1.1
PFS was defined as the time from study treatment initiation (Cycle 1 Day 1) to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Data for participants without PD or death as of the data cut-off date were censored at the time of the last tumor assessment.
Measured: From treatment initiation (Cycle 1 Day 1) until disease progression or death (Up to 43.3 months) (Cycle length= 14 days)
Secondary outcomes (16)
Parts A and B: Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs)
Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 4-fold (treatment-enhanced ADA response).
Measured: Baseline and Day 1 of Cycles 1 to 5; Day 1 of Cycle 7, and every 6 cycles thereafter (1 cycle is 14 days); study completion/discontinuation; safety follow-up visits (up to approximately 40.8 months - Part A and 45.4 months - Part B)
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood
Biomarker analyses were performed using peripheral blood samples that were collected from participants in Part B of the study. The blood samples were assessed by flow cytometry for absolute counts of CD3⁺CD8⁺ T cells and proliferating CD3⁺CD8⁺Ki67⁺ T cells.
Measured: Days 1, 2, and 8 of Cycles 1 and 5; Day 1 of Cycles 2, 3, and 9 (1 cycle is 14 days); study completion visit (28 days after last dose; up to 43.3 months); safety follow-up (SFU) (90 days after last dose; up to 45.4 months)
Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies
Fresh tumor biopsies were collected from participants in Part B of the study to assess changes in T-cell infiltration and activation within the tumor microenvironment. Tumor tissue was evaluated for CD8⁺ T-cell densities. The tumor tissue samples were collected at screening (archival metastasis and archival primary samples) and during the study (fresh samples).
Measured: At screening and Cycle 3 Day 1
Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig
Measured: Predose, half infusion, end of infusion (EOI), 0.5, 2, 4, and 8 hours postdose on Cycle 1 Day 1 and Cycle 5 Day 1, and on Cycles 1 and 5 Days 2, 3, 4, 5, 8, and 12, and predose on Day 1 of Cycles 2 and 6 (1 cycle = 14 days)
Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig
Measured: Predose, half infusion, end of infusion (EOI), 0.5, 2, 4, and 8 hours postdose on Cycle 1 Day 1 and Cycle 5 Day 1, and on Cycles 1 and 5 Days 2, 3, 4, 5, 8, and 12, and predose on Day 1 of Cycles 2 and 6 (1 cycle = 14 days)
Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig
Measured: Predose, half infusion, end of infusion (EOI), 0.5, 2, 4, and 8 hours postdose on Cycle 1 Day 1 and Cycle 5 Day 1, and on Cycles 1 and 5 Days 2, 3, 4, 5, 8, and 12, and predose on Day 1 of Cycles 2 and 6 (1 cycle = 14 days)
Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig
For participants who experienced an adverse event (AE) following infusion with lomvastomig, a delay of the next administration for up to two cycles was acceptable to allow for resolution of toxicity to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 2 or lower for hematological toxicities or Grade 1 or lower for non-hematological toxicities (with the exception of a toxicity considered as not related to study drug). In the case of a delayed administration, the predose PK sample for Day 1 of Cycles 2 and/or 6 could have been collected up to 28 days after the end of the previous treatment cycle.
Measured: Predose, half infusion, end of infusion (EOI), 0.5, 2, 4, and 8 hours postdose on Cycle 1 Day 1 and Cycle 5 Day 1, and on Cycles 1 and 5 Days 2, 3, 4, 5, 8, and 12, and predose on Day 1 of Cycles 2 and 6 (1 cycle = 14 days)
Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig
For participants who experienced an adverse event (AE) following infusion with lomvastomig, a delay of the next administration for up to two cycles was acceptable to allow for resolution of toxicity to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 2 or lower for hematological toxicities or Grade 1 or lower for non-hematological toxicities (with the exception of a toxicity considered as not related to study drug). In the case of a delayed administration, the predose PK sample for Day 1 of Cycles 2 and/or 6 could have been collected up to 28 days after the end of the previous treatment cycle.
Measured: Predose, half infusion, end of infusion (EOI), 0.5, 2, 4, and 8 hours postdose on Cycle 1 Day 1 and Cycle 5 Day 1, and on Cycles 1 and 5 Days 2, 3, 4, 5, 8, and 12, and predose on Day 1 of Cycles 2 and 6 (1 cycle = 14 days)
Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig
For participants who experienced an adverse event (AE) following infusion with lomvastomig, a delay of the next administration for up to two cycles was acceptable to allow for resolution of toxicity to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 2 or lower for hematological toxicities or Grade 1 or lower for non-hematological toxicities (with the exception of a toxicity considered as not related to study drug). In the case of a delayed administration, the predose PK sample for Day 1 of Cycles 2 and/or 6 could have been collected up to 28 days after the end of the previous treatment cycle.
Measured: Predose, half infusion, end of infusion (EOI), 0.5, 2, 4, and 8 hours postdose on Cycle 1 Day 1 and Cycle 5 Day 1, and on Cycles 1 and 5 Days 2, 3, 4, 5, 8, and 12, and predose on Day 1 of Cycles 2 and 6 (1 cycle = 14 days)
Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig
Measured: Predose, half infusion, end of infusion (EOI), 0.5, 2, 4, and 8 hours postdose on Cycle 1 Day 1 and Cycle 5 Day 1, and on Cycles 1 and 5 Days 2, 3, 4, 5, 8, and 12, and predose on Day 1 of Cycles 2 and 6 (1 cycle = 14 days)
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay
Blood samples were collected from participants in Part A of the study and different types of immune cells were assessed by flow cytometry for the percentage of receptor occupancy (RO) by lomvastomig. RO (or drug coverage) is used to quantify the binding of the therapeutic to its target on the cell surface. The RO of lomvastomig was determined on cells that were positive (+) for CD3+, CD4+, CD56+/16+, and CD8+.
Measured: Predose and EOI: Day 1 of Cycles 1 and 5; Predose: Day 1 of Cycles 2, 3, and 9; Postdose: Day 8 of Cycles 1 and 5 (1 cycle is 14 days); study completion (28 days after last dose; up to 39.7 months); SFU (60 days after last dose; up to 40.8 months)
Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0
AE=any untoward medical occurrence in a participant administered a pharmaceutical product \& which does not necessarily have a causal relationship with treatment \& can therefore be any unfavorable \& unintended sign (including abnormal laboratory values/abnormal clinical test results), symptoms/disease temporally associated with the use of pharmaceutical product, whether or not considered related to pharmaceutical product. Severity of AEs was graded as: Grade 1=Mild, asymptomatic/mild symptoms, clinical/diagnostic observations only, or intervention not indicated; Grade 2=Moderate, minimal, local/non-invasive intervention indicated, or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe/medically significant but not immediately life-threatening, hospitalization/prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4= Life-threatening consequences, urgent intervention indicated; Grade 5=Death related to AE.
Measured: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months)
Part A: ORR as Determined by Investigator Using RECIST v1.1
ORR was defined as the percentage of participants with an objective tumor response of CR or PR as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD.
Measured: Cycle 1 Day 1 then every 8 weeks for the first year; every 12 weeks thereafter until disease progression or treatment discontinuation (whichever occurs last), initiation of a new line of therapy or death (Up to 39.7 months) (Cycle length= 14 days)
Part A: DCR as Determined by Investigator Using RECIST v1.1
DCR was defined as the percentage of participants with an objective tumor response of CR, PR or SD as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Measured: Cycle 1 Day 1 then every 8 weeks for the first year; every 12 weeks thereafter until disease progression or treatment discontinuation (whichever occurs last), initiation of a new line of therapy or death (Up to 39.7 months) (Cycle length= 14 days)
Part A: DOR as Determined by Investigator Using RECIST v1.1
DOR was calculated for participants who had a best confirmed OR of CR/PR. DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurs first as determined by investigator assessment using RECIST v1.1. CR=the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR=at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Data for participants without PD or death from any cause as of the data cut-off date were censored at the time of the last tumor assessment.
Measured: From first occurrence of documented OR up to disease progression or death (Up to 39.7 months) (Cycle length= 14 days)
Part A: PFS as Determined by Investigator Using RECIST v1.1
PFS was defined as the time from study treatment initiation (Cycle 1 Day 1) to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Data for participants without PD or death as of the data cut-off date were censored at the time of the last tumor assessment.
Measured: From initiation of study treatment (Cycle 1 Day 1) until disease progression or death (Up to 39.7 months) (Cycle length= 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start15 Oct 2018
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708328
- Sponsor's protocol ID
- NP40435
- Other IDs
- 2018-000982-35, 2018
- Status last verified
- Aug 2025
- First submitted
- 9 Oct 2018
- Last updated
- 20 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rohrberg KS, Melero I, F Sanmamed M, Munoz-Couselo E, Cervantes A, Gambardella V, Greillier L, Garrido P, Kim HR, Lee DH, Italiano A, Cassier PA, Hiret S, Deva S, Kim TM, Blumenschein GR Jr, Lovendahl Eefsen R, Henick BS, Perro M, Umana P, Peixoto A, Lauener L, Weber P, Seeber S, Klein C, Higgins B, Guidi M, Kraus D, Mucke M, Heichinger C, Tran VL, Schmid D, Michielin F, Liu T, McIntyre C, Kao H, Codarri Deak L, Markert C, Moreno V. First-in-human study of lomvastomig, a PD-1-TIM-3 bispecific antibody, in patients with advanced and/or metastatic solid tumors. J Immunother Cancer. 2026 Jun 19;14(6):e012729. doi: 10.1136/jitc-2025-012729.
PubMed 42320980
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter, Dose Escalation and Expansion, Phase 1 Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7121661, a PD-1/TIM-3 Bispecific Antibody, in Patients With Advanced and/or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT03708328
- Acronym / sponsor ID
- NP40435
- Conditions
- Solid Tumors, Metastatic Melanoma, Non-small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC), Esophageal Squamous Cell Carcinoma (ESCC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Posted 20 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human, open-label, multicenter, Phase I multiple-ascending dose (MAD) study of single agent lomvastomig (RO7121661), an anti PD-1 (programmed death-1) and TIM-3 (T-cell immunoglobulin and mucin domain 3) bispecific antibody, for participants with advanced and/or metastatic solid tumors. The study consists of 2 parts: Dose Escalation (Part A) and Expansion (Parts B1, B2, B3, B4, and B5). The Dose Escalation part will be conducted first to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) based on safety, tolerability, pharmacokinetic, and/or the pharmacodynamic profile of escalating doses of lomvastomig. The Expansion part will enroll tumor-specific cohorts to evaluate anti-tumor activity of the MTD and/or RDE of lomvastomig from Part A (Q2W) and to confirm safety and tolerability in participants with selected tumor types.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Part A: Once Every 2 Weeks (Q2W) | Experimental | Drug: LomvastomigLomvastomig will be administered in treatment cycles once every 2 weeks (Q2W). Dose escalation will be carried out according to a modified continual reassessment method (mCRM) with escalation with overdose control (EWOC) design. |
| Expansion Part B1: Metastatic Melanoma Cohort | Experimental | Drug: LomvastomigThis cohort will comprise participants with checkpoint inhibitor (CPI) experienced, second line and beyond metastatic melanoma. The starting dose of lomvastomig for Expansion will be derived from the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) and the best dosing schedule determined during Dose Escalation. |
| Expansion Part B2: NSCLC Cohort 1 | Experimental | Drug: LomvastomigThis cohort will comprise participants with CPI and platinum experienced, second or third line PD-L1 positive non-small cell lung cancer (NSCLC). The starting dose of lomvastomig for Expansion will be derived from the MTD/RDE and the best dosing schedule determined during Dose Escalation. |
| Expansion Part B3: NSCLC Cohort 2 | Experimental | Drug: LomvastomigThis cohort will comprise participants with PD-L1 high, cancer immunotherapy (CIT) naïve first line NSCLC. The starting dose of lomvastomig for Expansion will be derived from the MTD/RDE and the best dosing schedule determined during Dose Escalation. This cohort was not initiated and no participants were enrolled in it. |
| Expansion Part B4: SCLC Cohort | Experimental | Drug: LomvastomigThis cohort will comprise participants with CPI naïve small cell lung cancer (SCLC) with prior failure of, progression on, or intolerance to, standard therapy. The starting dose of lomvastomig for Expansion will be derived from the MTD/RDE and the best dosing schedule determined during Dose Escalation. |
| Expansion Part B5: ESCC Cohort | Experimental | Drug: LomvastomigThis cohort will comprise participants with CPI-naïve esophageal squamous cell carcinoma (ESCC). The starting dose of lomvastomig for Expansion will be derived from the MTD/RDE and the best dosing schedule determined during Dose Escalation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Part A: Patient must have histologically or cytologically confirmed advanced and/or metastatic solid tumor malignancies for which standard curative or palliative measures do not exist, are no longer effective, or are not acceptable to the patient
- Eastern Cooperative Oncology Group Performance Status 0-1
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- Fresh biopsies may be required
- Negative HIV, hepatitis B, or hepatitis C test result
Key exclusion criteria (23 listed)
- Pregnancy, lactation, or breastfeeding
- Known hypersensitivity to any of the components of RO7121661
- Active or untreated central nervous system (CNS) metastases
- An active second malignancy
- Evidence of concomitant diseases, metabolic dysfunction, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
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 |
|---|---|---|
| LomvastomigAlso: RO7121661, RG7769Lomvastomig will be administered intravenously (IV) with a flat dose on the schedule described for each study arm. | Drug | Dose Escalation Part A: Once Every 2 Weeks (Q2W), Expansion Part B1: Metastatic Melanoma Cohort, Expansion Part B2: NSCLC Cohort 1, Expansion Part B3: NSCLC Cohort 2, Expansion Part B4: SCLC Cohort, Expansion Part B5: ESCC Cohort |
Primary outcome
Part A: Number of Participants With a Dose-Limiting Toxicity (DLT)
Time frame: From Cycle 1 Day 1 to Cycle 2 Day 7 (Cycle length= 14 days)
A DLT was defined as a clinically significant adverse event (AE) or significant laboratory abnormality: 1) occurring during DLT assessment period of 21 days; 2) considered to be related to study treatment RO7121661 by the Investigator; 3) is not attributed to disease progression or another clearly identifiable cause. Following AEs were considered DLTs: Hematological toxicities (Grade 4 neutropenia lasting >5 days, Grade ≥3 febrile neutropenia, Grade 4 thrombocytopenia lasting > 48 hours, Grade 3 thrombocytopenia associated with bleeding episodes, Grade 4 anemia, Grade ≥3 anemia with hemolysis); Non-hematological toxicity Grade ≥3 (Any Grade 3 immune-mediated AE, Grade 3 hyperbilirubinemia lasting for >48 hours/Grade 4 hyperbilirubinemia; Grade ≥3 aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations with hyperbilirubinemia of Grade ≥2, Grade 4 AST or ALT elevations, Grade ≥3 nausea, vomiting, or diarrhea, Grade ≥3 non-hematological laboratory abnormality.
Part A: Number of Participants With at Least One AE by Highest Severity, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Time frame: From signing of informed consent form up to 60 days after last treatment administration (up to 41.7 months)
AE=any untoward medical occurrence in a participant administered a pharmaceutical product \& which does not necessarily have a causal relationship with treatment \& can therefore be any unfavorable \& unintended sign (including abnormal laboratory values/abnormal clinical test results), symptoms/disease temporally associated with the use of pharmaceutical product, whether or not considered related to pharmaceutical product. Severity of AEs was graded as: Grade 1=Mild, asymptomatic/mild symptoms, clinical/diagnostic observations only, or intervention not indicated; Grade 2=Moderate, minimal, local/non-invasive intervention indicated, or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe/medically significant but not immediately life-threatening, hospitalization/prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4= Life-threatening consequences, urgent intervention indicated; Grade 5=Death related to AE.
Part B: Objective Response Rate (ORR) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Cycle 1 Day 1 then every 8 weeks for the first year; every 12 weeks thereafter until disease progression or treatment discontinuation (whichever occurs last), initiation of a new line of therapy or death (Up to 43.3 months) (Cycle length= 14 days)
ORR was defined as the percentage of participants with an objective tumor response of complete response (CR) or partial response (PR) as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD.
Part B: Disease Control Rate (DCR) as Determined by Investigator Using RECIST v1.1
Time frame: Cycle 1 Day 1 then every 8 weeks for the first year; every 12 weeks thereafter until disease progression or treatment discontinuation (whichever occurs last), initiation of a new line of therapy or death (Up to 43.3 months) (Cycle length= 14 days)
DCR was defined as the percentage of participants with an objective tumor response of CR, PR or stable disease (SD) as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression (PD). PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Part B: Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1
Time frame: From first occurrence of documented OR up to disease progression or death (Up to 43.3 months) (Cycle length = 14 days)
DOR was calculated for participants who had a best confirmed overall response (OR) of CR/PR. DOR was defined as time from first occurrence of a documented OR until the time of documented PD or death (within 30 days from last treatment) from any cause, whichever occurs first as determined by investigator assessment using RECIST v1.1. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Data for participants without PD or death as of the data cut-off date were censored at the time of the last tumor assessment.
Part B: Progression Free Survival (PFS) as Determined by Investigator Using RECIST v1.1
Time frame: From treatment initiation (Cycle 1 Day 1) until disease progression or death (Up to 43.3 months) (Cycle length= 14 days)
PFS was defined as the time from study treatment initiation (Cycle 1 Day 1) to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Data for participants without PD or death as of the data cut-off date were censored at the time of the last tumor assessment.
16 secondary outcomes
Parts A and B: Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs)
Time frame: Baseline and Day 1 of Cycles 1 to 5; Day 1 of Cycle 7, and every 6 cycles thereafter (1 cycle is 14 days); study completion/discontinuation; safety follow-up visits (up to approximately 40.8 months - Part A and 45.4 months - Part B)
Part B: Biomarkers: T-cell Proliferation/Activation in Peripheral Blood
Time frame: Days 1, 2, and 8 of Cycles 1 and 5; Day 1 of Cycles 2, 3, and 9 (1 cycle is 14 days); study completion visit (28 days after last dose; up to 43.3 months); safety follow-up (SFU) (90 days after last dose; up to 45.4 months)
Part B: Biomarkers: CD8+ T-cell Densities in Tumor Biopsies
Time frame: At screening and Cycle 3 Day 1
Parts A and B: Time to Maximum Observed Serum Concentration (Tmax) of Lomvastomig
Time frame: Predose, half infusion, end of infusion (EOI), 0.5, 2, 4, and 8 hours postdose on Cycle 1 Day 1 and Cycle 5 Day 1, and on Cycles 1 and 5 Days 2, 3, 4, 5, 8, and 12, and predose on Day 1 of Cycles 2 and 6 (1 cycle = 14 days)
Parts A and B: Maximum Observed Serum Concentration (Cmax) of Lomvastomig
Time frame: Predose, half infusion, end of infusion (EOI), 0.5, 2, 4, and 8 hours postdose on Cycle 1 Day 1 and Cycle 5 Day 1, and on Cycles 1 and 5 Days 2, 3, 4, 5, 8, and 12, and predose on Day 1 of Cycles 2 and 6 (1 cycle = 14 days)
Parts A and B: Maximum Observed Serum Concentration Dose Normalized (Cmax_D) of Lomvastomig
Time frame: Predose, half infusion, end of infusion (EOI), 0.5, 2, 4, and 8 hours postdose on Cycle 1 Day 1 and Cycle 5 Day 1, and on Cycles 1 and 5 Days 2, 3, 4, 5, 8, and 12, and predose on Day 1 of Cycles 2 and 6 (1 cycle = 14 days)
Parts A and B: Time to Last Non-zero Concentration (Tlast) of Lomvastomig
Time frame: Predose, half infusion, end of infusion (EOI), 0.5, 2, 4, and 8 hours postdose on Cycle 1 Day 1 and Cycle 5 Day 1, and on Cycles 1 and 5 Days 2, 3, 4, 5, 8, and 12, and predose on Day 1 of Cycles 2 and 6 (1 cycle = 14 days)
Parts A and B: Last Non-zero Concentration (Clast) of Lomvastomig
Time frame: Predose, half infusion, end of infusion (EOI), 0.5, 2, 4, and 8 hours postdose on Cycle 1 Day 1 and Cycle 5 Day 1, and on Cycles 1 and 5 Days 2, 3, 4, 5, 8, and 12, and predose on Day 1 of Cycles 2 and 6 (1 cycle = 14 days)
Parts A and B: Area Under the Curve From Dosing to Last Concentration (AUClast) of Lomvastomig
Time frame: Predose, half infusion, end of infusion (EOI), 0.5, 2, 4, and 8 hours postdose on Cycle 1 Day 1 and Cycle 5 Day 1, and on Cycles 1 and 5 Days 2, 3, 4, 5, 8, and 12, and predose on Day 1 of Cycles 2 and 6 (1 cycle = 14 days)
Parts A and B: Area Under the Curve From Dosing to 336 Hours Post-dose (AUC0-336 Hrs) of Lomvastomig
Time frame: Predose, half infusion, end of infusion (EOI), 0.5, 2, 4, and 8 hours postdose on Cycle 1 Day 1 and Cycle 5 Day 1, and on Cycles 1 and 5 Days 2, 3, 4, 5, 8, and 12, and predose on Day 1 of Cycles 2 and 6 (1 cycle = 14 days)
Part A: Receptor Occupancy (RO) of Lomvastomig, Assessed Via an Ex-Vivo Assay
Time frame: Predose and EOI: Day 1 of Cycles 1 and 5; Predose: Day 1 of Cycles 2, 3, and 9; Postdose: Day 8 of Cycles 1 and 5 (1 cycle is 14 days); study completion (28 days after last dose; up to 39.7 months); SFU (60 days after last dose; up to 40.8 months)
Part B: Number of Participants With at Least One AE by Highest Severity, Graded According to the NCI CTCAE v5.0
Time frame: From signing of informed consent form up to 90 days after last treatment administration (up to 46.2 months)
Part A: ORR as Determined by Investigator Using RECIST v1.1
Time frame: Cycle 1 Day 1 then every 8 weeks for the first year; every 12 weeks thereafter until disease progression or treatment discontinuation (whichever occurs last), initiation of a new line of therapy or death (Up to 39.7 months) (Cycle length= 14 days)
Part A: DCR as Determined by Investigator Using RECIST v1.1
Time frame: Cycle 1 Day 1 then every 8 weeks for the first year; every 12 weeks thereafter until disease progression or treatment discontinuation (whichever occurs last), initiation of a new line of therapy or death (Up to 39.7 months) (Cycle length= 14 days)
Part A: DOR as Determined by Investigator Using RECIST v1.1
Time frame: From first occurrence of documented OR up to disease progression or death (Up to 39.7 months) (Cycle length= 14 days)
Part A: PFS as Determined by Investigator Using RECIST v1.1
Time frame: From initiation of study treatment (Cycle 1 Day 1) until disease progression or death (Up to 39.7 months) (Cycle length= 14 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42320980Rohrberg KS, Melero I, F Sanmamed M, Munoz-Couselo E, Cervantes A, Gambardella V, Greillier L, Garrido P, Kim HR, Lee DH, Italiano A, Cassier PA, Hiret S, Deva S, Kim TM, Blumenschein GR Jr, Lovendahl Eefsen R, Henick BS, Perro M, Umana P, Peixoto A, Lauener L, Weber P, Seeber S, Klein C, Higgins B, Guidi M, Kraus D, Mucke M, Heichinger C, Tran VL, Schmid D, Michielin F, Liu T, McIntyre C, Kao H, Codarri Deak L, Markert C, Moreno V. First-in-human study of lomvastomig, a PD-1-TIM-3 bispecific antibody, in patients with advanced and/or metastatic solid tumors. J Immunother Cancer. 2026 Jun 19;14(6):e012729. doi: 10.1136/jitc-2025-012729.
- Individual participant dataSharing planned: No
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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.
Clinical Trials study director
Hoffmann-La Roche
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lomvastomig in people with Solid Tumors and Metastatic Melanoma, run by Hoffmann-La Roche at 17 sites in 6 countries.
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 25 inclusion and 23 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: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain, France, South Korea, United States, Denmark and 1 more country. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Part A: Number of Participants With a Dose-Limiting Toxicity (DLT) (time frame: From Cycle 1 Day 1 to Cycle 2 Day 7 (Cycle length= 14 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03708328, which also lists 1 linked publication.
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 20 Aug 2025.