Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

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 GDC-1971 SHP2 Carcinoma, Non-Small-Cell Lung 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 contraception, 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

  • Univ of Calif, San Francisco; Breast Cancer Center not yet accepting patients
    San Francisco California 94115 United States
  • City of Hope Comprehensive Cancer Center accepting new patients
    Duarte California 91010 United States

Details

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