A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Trial end date: 2025-10-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of RO7502175 when administered as a single agent and in combination with atezolizumab in adult participants with locally advanced or metastatic solid tumors, including non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Atezolizumab

Criteria

Inclusion Criteria:

• Life expectancy at least 12 weeks

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1

• Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy

• Tumor Specimen availability

Exclusion Criteria:

• Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment

• Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment

• Active hepatitis B or C or tuberculosis

• Positive test for human immunodeficiency virus (HIV) infection

• Acute or chronic active Epstein-Barr virus (EBV) infection at screening

• Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first RO7502175 infusion

• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases

• Active or history of autoimmune disease

• Prior allogeneic stem cell or organ transplantation