A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7759065 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

Last updated: May 12, 2025
Sponsor: Genentech, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

RO7759065

Atezolizumab

Clinical Study ID

NCT06488716
GO45296
  • Ages > 18
  • All Genders

Study Summary

This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7759065 as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib) in patients with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Several key aspects of the study design and study population are summarized below.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Life expectancy at least 12 weeks

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

  • Adequate hematologic and end-organ function

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

  • Histologically confirmed locally advanced, recurrent, or metastatic incurable solidtumor malignancy

  • Availability of representative tumor specimens required for patients in selectcohorts.

Exclusion

Exclusion Criteria:

  • Women who are pregnant or breastfeeding

  • Any anti-cancer therapy, whether investigational or approved, includingchemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior toinitiation 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 beforefirst RO7759065 infusion

  • Primary, untreated, or active central nervous system (CNS) metastases

  • Active or history of autoimmune disease or immune deficiency

  • Prior allogeneic stem cell or organ transplantation

  • Any history of a Grade 3 immune-mediated adverse event attributed to prior cancerimmunotherapy that resulted in permanent discontinuation of that agent

  • Any history of a Grade 4 immune-mediated adverse event attributed to prior cancerimmunotherapy.

Study Design

Total Participants: 310
Treatment Group(s): 2
Primary Treatment: RO7759065
Phase: 1
Study Start date:
December 16, 2024
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • British Columbia Cancer Agency

    Vancouver, British Columbia V5Z 4R2
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2MR
    Canada

    Active - Recruiting

  • Sir Mortimer B Davis Jewish General Hospital-3755 Cote Sainte-Catherine

    Montreal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • University of Colorado

    Aurora, Colorado 80045-2517
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Tennesse Oncology - NASH - SCRI - PPDS

    Chattanooga, Tennessee 37404-1130
    United States

    Active - Recruiting

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