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

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Locally Advanced or Metastatic Solid Tumors
Intervention / Treatment

-

Contacts and Locations

San Francisco

Stanford University', San Francisco, California, United States, 94305

Aurora

University Of Colorado, Aurora, Colorado, United States, 80045

Sarasota

Florida Cancer Specialists - Sarasota, Sarasota, Florida, United States, 34232

Atlanta

Winship Cancer Institute, Atlanta, Georgia, United States, 30322

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Detroit

Henry Ford Hospital, Detroit, Michigan, United States, 48202

Saint Louis

Washington University Medical Center, Division of Oncology, Saint Louis, Missouri, United States, 63110

New Brunswick

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States, 08901

Germantown

The West Clinic - Memphis (Union Ave), Germantown, Tennessee, United States, 38138

Nashville

SCRI Oncology Partners, Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Genentech, Inc.,

Study Record Dates

2026-08-31