RECRUITING

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab 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 Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.

Official Title

A Phase I, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

Quick Facts

Study Start:2023-11-27
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06031441

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. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  2. * Life expectancy \>=3 months, in the investigator's judgment
  3. * Adequate hematologic and end-organ function
  4. * Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy that has progressed after available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care
  5. * Measurable disease per RECIST v1.1
  6. * Tumor specimen availability, for certain cohorts
  1. * Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to C1D1, with certain exceptions
  2. * Active hepatitis B or C
  3. * Active tuberculosis
  4. * Positive test for HIV infection
  5. * Administration of a live, attenuated vaccine (e.g., Flumist) within 4 weeks prior to RO7566802 infusion
  6. * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  7. * Active or history of autoimmune disease
  8. * Prior allogeneic stem cell or organ transplantation
  9. * Uncontrolled tumor-related pain
  10. * Significant cardiovascular disease

Contacts and Locations

Study Contact

Reference Study ID Number: GO44431 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

University of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35233
United States
Yale Cancer Center
New Haven, Connecticut, 06520
United States
Icahn School of Medicine at Mount Sinai (ISMMS); The Derald H. Ruttenberg Treatment Center
New York, New York, 10029
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States

Collaborators and Investigators

Sponsor: Genentech, Inc.

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

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 Date2023-11-27
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-11-27
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Locally Advanced Solid Tumors
  • Recurrent Solid Tumors
  • Metastatic Solid Tumors