RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-10-20
Study Completion:2027-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05581004

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Life expectancy at least 12 weeks
  2. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  3. * Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1
  4. * Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
  5. * Tumor Specimen availability
  1. * 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
  2. * Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment
  3. * Active hepatitis B or C or tuberculosis
  4. * Positive test for human immunodeficiency virus (HIV) infection
  5. * Acute or chronic active Epstein-Barr virus (EBV) infection at screening
  6. * Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first RO7502175 infusion
  7. * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  8. * Active or history of autoimmune disease
  9. * Prior allogeneic stem cell or organ transplantation

Contacts and Locations

Study Contact

Reference Study ID Number: GO43860 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Study Locations (Sites)

Stanford University
San Francisco, California, 94305
United States
University Of Colorado
Aurora, Colorado, 80045
United States
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34232
United States
Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Washington University Medical Center, Division of Oncology
St Louis, Missouri, 63110
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
The West Clinic - Memphis (Union Ave)
Germantown, Tennessee, 38138
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 98229
United States

Collaborators and Investigators

Sponsor: Genentech, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-20
Study Completion Date2027-02-28

Study Record Updates

Study Start Date2022-10-20
Study Completion Date2027-02-28

Terms related to this study

Additional Relevant MeSH Terms

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