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

Inclusion criteria

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-immunotherapy-drugs-are-boosting-survival/" >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

Exclusion criteria

Pregnancy, lactation, or breastfeeding
Known hypersensitivity to any of the components of RO7247669
Active or untreated central nervous system (CNS) metastases
An active second malignancy
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
Positive HIV, hepatitis B, or hepatitis C test result
Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infection
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
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 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

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