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

  • STATUS
    Recruiting
  • End date
    Aug 2, 2023
  • participants needed
    498
  • sponsor
    Genentech, Inc.
Updated on 27 October 2022
KRAS
erlotinib
bevacizumab
cetuximab
solid tumour
atezolizumab
ki-ras

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.

Details
Condition Non-Small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumors
Treatment Cetuximab, bevacizumab, Erlotinib, Atezolizumab, GDC-6036, Inavolisib, GDC-1971
Clinical Study IdentifierNCT04449874
SponsorGenentech, Inc.
Last Modified on27 October 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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