Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors

Prior treatment

• Vaccination with live vaccines within 28 days prior to Cycle 1 Day 1
• Treatment with oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
• 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 therapy with any immunomodulatory agents
  • Additional Specific Exclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously did not Receive Treatment for Metastatic Disease
• Prior therapy for metastatic disease is not permitted
• Neo-adjuvant anti-PD-1 or anti-PD-L1 therapy is not allowed

Other illness

• Known hypersensitivity to any of the components of RO7247669
• An active second malignancy
• Positive HIV, hepatitis B, or hepatitis C test result
• Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infection
• Active or history of autoimmune disease or immune deficiency

Lab values

• Evidence of concomitant diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding 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
• Prior treatment with a lymphocyte activation gene-3 (LAG-3) inhibitor
  • Additional Specific Exclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously Received Treatment for Metastatic Disease
• Participants with the following muations, rearrangements, translocations are not eligible: EGFR, ALK, ROS1, BRAFV600E, and NTRK
  • Additional Specific Exclusion Criteria for Participants with Esophageal Squamous Cell Carcinoma

Other

• Pregnancy, lactation, or breastfeeding
• Active or untreated central nervous system (CNS) metastases

• 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
• Fresh biopsies may be required
• 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
• Not more than 2 prior lines of treatment for metastatic disease are allowed prior to enrolling in the study
• Prior treatment with an approved anti-PD-1 or anti-PD-L1 agent
  • Additional Specific Inclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously Received Treatment for Metastatic Disease
• Participants with histologically confirmed advanced non-small cell lung cancer
• Not more than 2 prior lines of treatment for metastatic disease are allowed prior to enrolling in the study
• Previously treated with approved PD-L1/PD-1 inhibitors
• 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 Esophageal Squamous Cell Carcinoma
• Participants whose major lesion was histologically confirmed as squamous cell carcinoma or adenosquamous cell carcinoma of the esophagus
• Participants who have previously received not more than 1 prior line of treatment for metastatic disease prior to enrolling in the study
  • Additional Specific Inclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously did not Receive Treatment for Metastatic Disease
• Participants with histologically confirmed advanced non-small cell lung cancer
• Tumor PD-L1 expression as determined by immunohistochemistry assay of archival tumor tissue or tissue obtained at screening