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

Last updated: April 24, 2025
Sponsor: Genentech, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Pelvic Cancer

Rectal Cancer

Gastric Cancer

Treatment

Pembrolizumab

RO7502175

Atezolizumab

Clinical Study ID

NCT05581004
GO43860
2021-006708-34
  • Ages > 18
  • All Genders

Study 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

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 solidtumor malignancy

  • Tumor Specimen availability

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding or intention of becoming pregnant during the study orwithin 4 months after the final dose of RO7501275, or 4 months after the final doseof pembrolizumab, or 5 months after the final dose of atezolizumab

  • Any anti-cancer therapy, whether investigational or approved, includingchemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiationof 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 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

Study Design

Total Participants: 450
Treatment Group(s): 3
Primary Treatment: Pembrolizumab
Phase: 1
Study Start date:
October 20, 2022
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • Kinghorn Cancer Centre

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • Kinghorn Cancer Centre; St Vincents Hospital

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • Monash Health Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Linear Clinical Research Ltd

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • UZ Antwerpen

    Edegem, 2650
    Belgium

    Active - Recruiting

  • CHU de Liège

    Herstal, 4040
    Belgium

    Active - Recruiting

  • CHU de Liège

    Liège, 4000
    Belgium

    Site Not Available

  • GasthuisZusters Antwerpen

    Wilrijk, 2610
    Belgium

    Active - Recruiting

  • British Columbia Cancer Agency

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • Ottawa Hospital Regional Cancer Centre

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 1Z5
    Canada

    Active - Recruiting

  • Sir Mortimer B Davis Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • Asan Medical Center - PPDS

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center - PPDS

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy

    Seoul, 120-752
    Korea, Republic of

    Active - Recruiting

  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX
    Netherlands

    Active - Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • ICO l?Hospitalet ? Hospital Duran i Reynals

    L?Hospitalet De Llobregat, Barcelona 08908
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario 12 De Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • START MADRID_Hospital Universiario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Malaga, 29010
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Stanford University

    San Francisco, California 94305
    United States

    Active - Recruiting

  • Stanford University'

    San Francisco, California 94305
    United States

    Active - Recruiting

  • University Of Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Florida Cancer Specialists - Sarasota

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Washington University Medical Center, Division of Oncology

    Saint Louis, Missouri 63110
    United States

    Completed

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • The West Clinic - Memphis (Union Ave)

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • SCRI Tennessee Oncology Nashville

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio, Texas 98229
    United States

    Active - Recruiting

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