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A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

Recruiting
18 years and older
All
Phase 1

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Overview

This is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.

Eligibility

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Life expectancy >=3 months, in the investigator's judgment
  • Adequate hematologic and end-organ function
  • Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy that has progressed after available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care
  • Measurable disease per RECIST v1.1
  • Tumor specimen availability, for certain cohorts

Exclusion Criteria:

  • Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to Cycle 1 Day 1, with certain exceptions
  • Active hepatitis B or C
  • Active tuberculosis
  • Positive test for human immunodeficiency virus (HIV) infection
  • Administration of a live, attenuated vaccine (e.g., Flumist) within 4 weeks prior to RO7566802 infusion
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Active or history of autoimmune disease
  • Prior allogeneic stem cell or organ transplantation
  • Uncontrolled tumor-related pain
  • Significant cardiovascular disease

Other protocol-defined inclusion/exclusion criteria may apply.

Study details
    Locally Advanced Solid Tumors
    Recurrent Solid Tumors
    Metastatic Solid Tumors

NCT06031441

Genentech, Inc.

7 August 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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