TERMINATED

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7759065 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

Conditions

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 Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7759065 as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib) in patients with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Several key aspects of the study design and study population are summarized below.

Official Title

A Phase Ia/Ib, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7759065 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

Quick Facts

Study Start:2024-12-16
Study Completion:2025-11-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06488716

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. * Adequate hematologic and end-organ function
  4. * Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1
  5. * Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
  6. * Availability of representative tumor specimens required for patients in select cohorts.
  1. * Women who are pregnant or breastfeeding
  2. * Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/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 RO7759065 infusion
  7. * Primary, untreated, or active central nervous system (CNS) metastases
  8. * Active or history of autoimmune disease or immune deficiency
  9. * Prior allogeneic stem cell or organ transplantation
  10. * Any history of a Grade 3 immune-mediated adverse event attributed to prior cancer immunotherapy that resulted in permanent discontinuation of that agent
  11. * Any history of a Grade 4 immune-mediated adverse event attributed to prior cancer immunotherapy.

Contacts and Locations

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Genentech, Inc.

Study Locations (Sites)

City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
University of Colorado
Aurora, Colorado, 80045-2517
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Tennesse Oncology - NASH - SCRI - PPDS
Chattanooga, Tennessee, 37404-1130
United States

Collaborators and Investigators

Sponsor: Genentech, Inc.

  • Clinical Trials, STUDY_DIRECTOR, 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 Date2024-12-16
Study Completion Date2025-11-05

Study Record Updates

Study Start Date2024-12-16
Study Completion Date2025-11-05

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumour