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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

NCT ID: NCT05581004

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-20

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Locally Advanced or Metastatic Solid Tumors NSCLC HNSCC Melanoma TNBC Esophageal Cancer Gastric Cancer Cervical Cancer Colorectal Cancer Urothelial Carcinoma Clear Cell RCC HCC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase Ia: Dose Escalation

Participants in successive cohorts will receive escalating doses of RO7502175, as an intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

RO7502175

Intervention Type DRUG

RO7502175 will be administered as per the schedules specified in the respective arms.

Phase Ia: Expansion

Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ia Dose Escalation phase as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

RO7502175

Intervention Type DRUG

RO7502175 will be administered as per the schedules specified in the respective arms.

Phase Ib: Dose Escalation

Participants in successive cohorts will receive escalating doses of RO7502175, as an IV infusion, in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

RO7502175

Intervention Type DRUG

RO7502175 will be administered as per the schedules specified in the respective arms.

Atezolizumab

Intervention Type DRUG

Atezolizumab will be administered as per the schedules specified in the respective arms.

Phase Ib: Expansion

Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ib Dose Escalation phase, as an IV infusion, in combination with a fixed dose of atezolizumab or pembrolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

RO7502175

Intervention Type DRUG

RO7502175 will be administered as per the schedules specified in the respective arms.

Atezolizumab

Intervention Type DRUG

Atezolizumab will be administered as per the schedules specified in the respective arms.

Pembrolizumab

Intervention Type DRUG

Pembrolizumab will be administered as per the schedules specified in the respective arms.

Interventions

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RO7502175

RO7502175 will be administered as per the schedules specified in the respective arms.

Intervention Type DRUG

Atezolizumab

Atezolizumab will be administered as per the schedules specified in the respective arms.

Intervention Type DRUG

Pembrolizumab

Pembrolizumab will be administered as per the schedules specified in the respective arms.

Intervention Type DRUG

Eligibility Criteria

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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 solid tumor malignancy
* Tumor Specimen availability

Exclusion Criteria

* Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of RO7501275, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab
* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation 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 before first 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stanford University

San Francisco, California, United States

Site Status RECRUITING

University Of Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Florida Cancer Specialists - Sarasota

Sarasota, Florida, United States

Site Status RECRUITING

Winship Cancer Institute

Atlanta, Georgia, United States

Site Status COMPLETED

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Henry Ford Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Washington University Medical Center, Division of Oncology

St Louis, Missouri, United States

Site Status COMPLETED

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status RECRUITING

The West Clinic - Memphis (Union Ave)

Germantown, Tennessee, United States

Site Status RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, United States

Site Status RECRUITING

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States

Site Status RECRUITING

Kinghorn Cancer Centre

Darlinghurst, New South Wales, Australia

Site Status RECRUITING

Monash Health Monash Medical Centre

Clayton, Victoria, Australia

Site Status RECRUITING

Linear Clinical Research Ltd

Nedlands, Western Australia, Australia

Site Status RECRUITING

UZ Antwerpen

Edegem, , Belgium

Site Status RECRUITING

CHU de Liège

Herstal, , Belgium

Site Status RECRUITING

GasthuisZusters Antwerpen

Wilrijk, , Belgium

Site Status RECRUITING

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Site Status RECRUITING

Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, Canada

Site Status RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Sir Mortimer B Davis Jewish General Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

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

Chaïdári, Attica, Greece

Site Status RECRUITING

Papageorgiou General Hospital of Thessaloniki

N. Efkapria-Pavlos Melas, Thessaloniki, Greece

Site Status RECRUITING

Sotiria Thoracic Diseases Hospital of Athens

Athens, , Greece

Site Status RECRUITING

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, , Netherlands

Site Status RECRUITING

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Asan Medical Center - PPDS

Seoul, , South Korea

Site Status COMPLETED

Samsung Medical Center - PPDS

Seoul, , South Korea

Site Status RECRUITING

Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy

Seoul, , South Korea

Site Status RECRUITING

ICO l?Hospitalet ? Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

Barcelona, , Spain

Site Status RECRUITING

START MADRID_Hospital Universiario Fundacion Jimenez Diaz

Madrid, , Spain

Site Status COMPLETED

Hospital Universitario 12 De Octubre

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Site Status RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Site Status RECRUITING

Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Site Status RECRUITING

Karolinska Universitetssjukhuset Solna

Stokholm, Solna, , Sweden

Site Status RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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United States Australia Belgium Canada Greece Netherlands South Korea Spain Sweden Taiwan

Central Contacts

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Reference Study ID Number: GO43860 https://forpatients.roche.com/

Role: CONTACT

Phone: 888-662-6728 (U.S. Only)

Email: [email protected]

Other Identifiers

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2021-006708-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GO43860

Identifier Type: -

Identifier Source: org_study_id