NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Hoffmann-La Roche
Conditions: Solid Tumors, Metastatic Melanoma, Non-small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC), Esophageal Squamous Cell Carcinoma (ESCC)
Interventions: Lomvastomig
Countries: United States, Denmark, France, New Zealand, South Korea, Spain
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: 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 * 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 Exclusion Criteria: 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 * 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
- New York, New York, United States
- Houston, Texas, United States
- Herlev, Denmark
- København Ø, Denmark
- Bordeaux, France
- Lyon, France
- Marseille, France
- Saint-Herblain, France
- Auckland, New Zealand
- Seoul, South Korea
- Seoul, South Korea
- Seoul, South Korea
- Pamplona, Navarre, Spain
- Barcelona, Spain
- Madrid, Spain
- Madrid, Spain
- Valencia, Spain