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Evaluating GDC-6036 for advanced solid tumors with KRAS G12C mutation

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

Phase 1 Interventional Genentech, Inc. · NCT04449874

This study is testing a new drug called GDC-6036 to see if it can help people with advanced solid tumors that have a specific KRAS G12C mutation.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment498 (estimated)
Ages18 Years and up
SexAll
SponsorGenentech, Inc. Industry-sponsored
Locations74 sites (Duarte, California and 73 other locations)
Trial IDNCT04449874 on ClinicalTrials.gov

What this trial studies

This Phase I interventional study aims to assess the safety, pharmacokinetics, and preliminary activity of GDC-6036, both alone and in combination with other treatments, in patients with advanced or metastatic solid tumors harboring a KRAS G12C mutation. The study will involve a dose-escalation and dose-expansion approach to determine the optimal dosing and effectiveness of the drug. Participants will be closely monitored for safety and response to treatment throughout the study.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically documented advanced or metastatic solid tumors that have a KRAS G12C mutation.

Not a fit: Patients with active brain metastases or significant malabsorption issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new targeted therapy option for patients with specific advanced solid tumors.

How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Where this trial is running

Duarte, California and 73 other locations

+24 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Small Cell Lung CancerColorectal CancerAdvanced Solid TumorsKRAS G12CGDC-6036Metastatic Solid TumorAtezolizumabBevacizumab
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.