A Study of RO7617991 in Patients With Locally Advanced or Metastatic MAGE-A4-Positive Solid Tumors

A Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7617991 in HLA-A*02-Positive Patients With Locally Advanced and/or Metastatic MAGE-A4-Positive Solid Tumors

This study will evaluate the safety, tolerability, and pharmacokinetics of RO7617991, and will make a preliminary assessment of the anti-tumor activity of RO7617991 in human leukocyte antigen (HLA)-A*02 eligible patients with locally advanced or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive solid tumors.

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Body weight ≥40 kilograms
• Life expectancy of at least 12 weeks
• Confirmed eligible HLA-A*02 genotype and tumor with confirmed MAGE-A4 expression
• Histologically confirmed locally advanced or metastatic solid tumor malignancy that has relapsed or is refractory to established therapies
• Measurable disease, according to RECIST v1.1
• Adequate hematologic and end-organ function
• Resolution to Grade ≤2 of all acute, clinically significant treatment-related toxicity from prior therapy
• An archival tumor tissue specimen or fresh baseline biopsy (when archival is not available) is required

Exclusion Criteria:

• Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of RO7617991 or tocilizumab
• Clinically significant cardiopulmonary dysfunction
• Clinically significant liver disease
• Poorly controlled Type 2 diabetes mellitus
• Active hepatitis B or C infection
• Positive test for human immunodeficiency virus (HIV)
• History of allergic reactions to red meat or tick bites or known galactose-alpha-1,3-galactose (alpha-gal) hypersensitivity
• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
• Symptomatic pleural effusion, pericardial effusion, or ascites or any prior procedural intervention for pleural effusion, pericardial effusion, or ascites within 6 weeks prior to enrollment
• Active or history of autoimmune disease or immune deficiency
• Treatment with systemic immunosuppressive medications
• Prior allogeneic stem cell or solid organ transplantation