A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors
About the study
Who can take part
INCLUSION CRITERIA
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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Study’s details
Contition
Solid Tumors,Metastatic Melanoma,Non-small Cell Lung Cancer (NSCLC),Small Cell Lung Cancer (SCLC),Esophageal Squamous Cell Carcinoma (ESCC)
Age (in years)
18+
Phase
Phase 1
Participants needed
134
Est. Completion Date
Apr 30, 2024
Treatment type
Interventional
Sponsor
Hoffmann-La Roche
ClinicalTrials.gov identifier
NCT03708328
Study number
NP40435
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?