ACTIVE_NOT_RECRUITING

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

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 Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.

Official Title

A Phase Ia/Ib Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 as a Single Agent and in Combination With Other Anti-cancer Therapies in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

Quick Facts

Study Start:2020-07-29
Study Completion:2026-09-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04449874

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. * Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.
  2. * Women of childbearing potential must agree to remain abstinent or use contraception, and agree to refrain from donating eggs during the treatment period and after the final dose of study treatment as specified in the protocol.
  3. * Men who are not surgically sterile must agree to remain abstinent or use a condom, and agreement to refrain from donating sperm during the treatment period and after the final dose of study treatment as specified in the protocol.
  1. * Active brain metastases.
  2. * Malabsorption or other condition that interferes with enteral absorption.
  3. * Clinically significant cardiovascular dysfunction or liver disease.

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
UCSD Moores Cancer Center
La Jolla, California, 92093
United States
Chao Family Comprehensive Cancer Center UCI
Orange, California, 92868
United States
Yale Cancer Center
New Haven, Connecticut, 06511
United States
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34232
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104
United States
Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
United States
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
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 Date2020-07-29
Study Completion Date2026-09-24

Study Record Updates

Study Start Date2020-07-29
Study Completion Date2026-09-24

Terms related to this study

Keywords Provided by Researchers

  • KRAS G12C
  • Non-Small Cell Lung Cancer
  • Colorectal Cancer
  • GDC-6036
  • Metastatic Solid Tumor
  • Atezolizumab
  • Bevacizumab
  • Cetuximab
  • Erlotinib
  • Inavolisib
  • GDC-1971
  • SHP2

Additional Relevant MeSH Terms

  • Non-Small Cell Lung Cancer
  • Colorectal Cancer
  • Advanced Solid Tumors