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: September 18, 2025
Sponsor: Genentech, Inc.
Overall Status: Suspended

Phase

1

Condition

Neoplasms

Treatment

RO7759065

Atezolizumab

Clinical Study ID

NCT06488716
GO45296
2024-513391-17-00
  • 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 01, 2027

Connect with a study center

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • St Vincent's Hospital Sydney

    Darlinghurst 2169378, New South Wales 2155400 2010
    Australia

    Site Not Available

  • British Columbia Cancer Agency

    Vancouver, British Columbia V5Z 4R2
    Canada

    Site Not Available

  • British Columbia Cancer Agency

    Vancouver 6173331, British Columbia 5909050 V5Z 4R2
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2MR
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto 6167865, Ontario 6093943 M5G 2MR
    Canada

    Site Not Available

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

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

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

    Montreal 6077243, Quebec 6115047 H3T 1E2
    Canada

    Site Not Available

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Clinica Universidad de Navarra

    Pamplona 3114472, Navarre 3115609 31008
    Spain

    Site Not Available

  • Clinica Universidad de Navarra-Madrid

    Madrid, 28027
    Spain

    Site Not Available

  • Clinica Universidad de Navarra-Madrid

    Madrid 3117735, 28027
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia 2509954, 46010
    Spain

    Site Not Available

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010
    United States

    Site Not Available

  • City of Hope Comprehensive Cancer Center

    Duarte 5344147, California 5332921 91010
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045-2517
    United States

    Site Not Available

  • University of Colorado

    Aurora 5412347, Colorado 5417618 80045-2517
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick 5101717, New Jersey 5101760 08901
    United States

    Site Not Available

  • Tennesse Oncology - NASH - SCRI - PPDS

    Chattanooga, Tennessee 37404-1130
    United States

    Site Not Available

  • Tennesse Oncology - NASH - SCRI - PPDS

    Chattanooga 4612862, Tennessee 4662168 37404-1130
    United States

    Site Not Available

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