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

a study on Lung Cancer Non-Small Cell Lung Cancer Colorectal Cancer Solid Tumor Colorectal Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCSD UCSF
Dates
study started
completion around
Principal Investigator
by Pamela Munster (ucsf)
Headshot of Pamela Munster
Pamela Munster

Description

Summary

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

Keywords

Non-Small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumors, KRAS G12C, GDC-6036, Metastatic Solid Tumor, Atezolizumab, Bevacizumab, Cetuximab, Erlotinib, Inavolisib, GDC-1971, SHP2, Non-Small-Cell Lung Carcinoma, Colorectal Neoplasms, Erlotinib Hydrochloride

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.
  • 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.
  • 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.

You CAN'T join if...

  • Active brain metastases.
  • Malabsorption or other condition that interferes with enteral absorption.
  • Clinically significant cardiovascular dysfunction or liver disease.

Locations

  • UCSD Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Chao Family Comprehensive Cancer Center UCI accepting new patients
    Orange California 92868 United States
  • Univ of Calif, San Francisco; Breast Cancer Center withdrawn
    San Francisco California 94115 United States
  • City of Hope Comprehensive Cancer Center completed
    Duarte California 91010 United States

Lead Scientist at University of California Health

  • Pamela Munster (ucsf)
    Professor, Medicine, School of Medicine. Authored (or co-authored) 156 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genentech, Inc.
ID
NCT04449874
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 498 study participants
Last Updated