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: February 16, 2026
Sponsor: Genentech, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Esophageal Cancer

Pelvic Cancer

Gastric Cancer

Treatment

Pembrolizumab

Atezolizumab

RO7502175

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

    Site Not Available

  • Kinghorn Cancer Centre; St Vincents Hospital

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • Kinghorn Cancer Centre

    Darlinghurst 2169378, New South Wales 2155400 2010
    Australia

    Active - Recruiting

  • Monash Health Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Monash Health Monash Medical Centre

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Active - Recruiting

  • Linear Clinical Research Ltd

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Linear Clinical Research Ltd

    Nedlands 2064874, Western Australia 2058645 6009
    Australia

    Active - Recruiting

  • UZ Antwerpen

    Edegem, 2650
    Belgium

    Site Not Available

  • UZ Antwerpen

    Edegem 2799007, 2650
    Belgium

    Active - Recruiting

  • CHU de Liège

    Herstal, 4040
    Belgium

    Site Not Available

  • CHU de Liège

    Herstal 2795930, 4040
    Belgium

    Active - Recruiting

  • CHU de Liège

    Liège, 4000
    Belgium

    Site Not Available

  • GasthuisZusters Antwerpen

    Wilrijk, 2610
    Belgium

    Site Not Available

  • GasthuisZusters Antwerpen

    Wilrijk 2783615, 2610
    Belgium

    Active - Recruiting

  • British Columbia Cancer Agency

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • British Columbia Cancer Agency

    Vancouver 6173331, British Columbia 5909050 V5Z 4E6
    Canada

    Active - Recruiting

  • Ottawa Hospital Regional Cancer Centre

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 1Z5
    Canada

    Site Not Available

  • Ottawa Hospital Regional Cancer Centre

    Ottawa 6094817, Ontario 6093943 K1H 8L6
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto 6167865, Ontario 6093943 M5G 1Z5
    Canada

    Active - Recruiting

  • Sir Mortimer B Davis Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • Sir Mortimer B Davis Jewish General Hospital

    Montreal 6077243, Quebec 6115047 H3T 1E2
    Canada

    Active - Recruiting

  • University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA

    Chaïdári 260183, Attica 6692632 124 62
    Greece

    Active - Recruiting

  • University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA

    Chaidari, Attiki 124 62
    Greece

    Site Not Available

  • Papageorgiou General Hospital of Thessaloniki

    N. Efkapria-Pavlos Melas, Thessaloniki 564 03
    Greece

    Site Not Available

  • Papageorgiou General Hospital of Thessaloniki

    Pavlos Melas, Thessaloniki 564 03
    Greece

    Active - Recruiting

  • Sotiria Thoracic Diseases Hospital of Athens

    Athens, 115 27
    Greece

    Site Not Available

  • Sotiria Thoracic Diseases Hospital of Athens

    Athens 264371, 115 27
    Greece

    Active - Recruiting

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki 734077, 564 03
    Greece

    Site Not Available

  • 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

    Site Not Available

  • 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

    Site Not Available

  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam 2759794, 1066 CX
    Netherlands

    Active - Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Groningen

    Groningen 2755251, 9713 GZ
    Netherlands

    Active - Recruiting

  • Asan Medical Center - PPDS

    Seoul 1835848, 05505
    South Korea

    Completed

  • Samsung Medical Center - PPDS

    Seoul 1835848, 06351
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Active - Recruiting

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

    Seoul 1835848, 120-752
    South Korea

    Active - Recruiting

  • ICO Hospitalet- Hospital Duran i Reynals

    L'Hospitalet de Llobregat 3120619, Barcelona 08908
    Spain

    Active - Recruiting

  • ICO L'Hospitalet Hospital Duran I Reynals

    L'Hospitalet de Llobregat 3120619, Barcelona 08908
    Spain

    Active - Recruiting

  • ICO l?Hospitalet ? Hospital Duran i Reynals

    L'Hospitalet de Llobregat 3120619, Barcelona 08908
    Spain

    Active - Recruiting

  • ICO l?Hospitalet ? Hospital Duran i Reynals

    L?Hospitalet De Llobregat, Barcelona 08908
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

    Barcelona, 08035
    Spain

    Site Not Available

  • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario 12 De Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • START MADRID_Hospital Universiario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario 12 De Octubre

    Madrid 3117735, 28041
    Spain

    Active - Recruiting

  • START MADRID_Hospital Universiario Fundacion Jimenez Diaz

    Madrid 3117735, 28040
    Spain

    Completed

  • Hospital Universitario Virgen de la Victoria

    Malaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria

    Málaga 2514256, 29010
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia 2509954, 46010
    Spain

    Active - Recruiting

  • Karolinska Universitetssjukhuset Solna

    Stockholm 2673730, Solna 17176
    Sweden

    Site Not Available

  • Sahlgrenska Universitetssjukhuset

    Goteborg, 413 45
    Sweden

    Site Not Available

  • Sahlgrenska Universitetssjukhuset

    Gothenburg 2711537, 413 45
    Sweden

    Active - Recruiting

  • Karolinska Universitetssjukhuset Solna

    Stokholm, Solna, 17176
    Sweden

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City 1673820, 807
    Taiwan

    Active - Recruiting

  • Chung Shan Medical University Hospital

    Taichung, 40201
    Taiwan

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung 1668399, 40201
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei 1668341, 10002
    Taiwan

    Active - Recruiting

  • Stanford University

    San Francisco, California 94305
    United States

    Site Not Available

  • Stanford University'

    San Francisco, California 94305
    United States

    Active - Recruiting

  • Stanford University

    San Francisco 5391959, California 5332921 94305
    United States

    Active - Recruiting

  • University Of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University Of Colorado

    Aurora 5412347, Colorado 5417618 80045
    United States

    Active - Recruiting

  • Florida Cancer Specialists - Sarasota

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Florida Cancer Specialists - Sarasota

    Sarasota 4172131, Florida 4155751 34232
    United States

    Active - Recruiting

  • Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Winship Cancer Institute

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Completed

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit 4990729, Michigan 5001836 48202
    United States

    Active - Recruiting

  • Washington University Medical Center, Division of Oncology

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University Medical Center, Division of Oncology

    St Louis 4407066, Missouri 4398678 63110
    United States

    Completed

  • 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

    Active - Recruiting

  • The West Clinic - Memphis (Union Ave)

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • SCRI Tennessee Oncology Nashville

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • The West Clinic - Memphis (Union Ave)

    Germantown 4624601, Tennessee 4662168 38138
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio, Texas 98229
    United States

    Site Not Available

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio 4726206, Texas 4736286 98229
    United States

    Active - Recruiting

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