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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors

NCT05581004•Genentech, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (41)

Stanford University

San Francisco, California, United States

University Of Colorado

Aurora, Colorado, United States

Florida Cancer Specialists - Sarasota

Sarasota, Florida, United States

Winship Cancer Institute

Atlanta, Georgia, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Washington University Medical Center, Division of Oncology

St Louis, Missouri, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

The West Clinic - Memphis (Union Ave)

Germantown, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Key Dates

Start Date

October 20, 2022

Primary Completion Date

February 28, 2027

Completion Date

February 28, 2027

Last Updated

February 17, 2026

Enrollment

450

ESTIMATED participants

Conditions

Locally Advanced or Metastatic Solid TumorsNSCLCHNSCCMelanomaTNBCEsophageal CancerGastric CancerCervical CancerColorectal CancerUrothelial CarcinomaClear Cell RCCHCC

Interventions

RO7502175

DRUG

Atezolizumab

DRUG

Pembrolizumab

DRUG

Contacts

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

CONTACT

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

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