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Recruiting Phase 1 NCT05581004

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

Trial Parameters

Condition Locally Advanced or Metastatic Solid Tumors
Sponsor Genentech, Inc.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 450
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-10-20
Completion 2027-02-28
Interventions
RO7502175AtezolizumabPembrolizumab

Brief 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 or pembrolizumab 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, colorectal cancer (CRC), 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.

Eligibility 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 intention of becoming pregnant during the study or within 4 months after the final dose of RO7501275, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab * 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,

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