ClinTrial Refer

Trial Acronym
GO42144

Registration Number
NCT04449874

Scientific 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

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.

-  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 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.

-  Active brain metastases.

    -  Malabsorption or other condition that interferes with enteral absorption.

    -  Clinically significant cardiovascular dysfunction or liver disease.

Genentech, Inc.

Website URL

Link Name

Link URL

ANZCTR

http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=NCT04449874

Clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT04449874

Secondary IDs
2020-000084-22GO42144

Study Type
Interventional

Intervention Code
Treatment - Drugs

Phase
Phase 1

Minimum Age
18

Maximum Age
100

Date Registered
23/03/2021

Date Closed
N/A

Status
Closed

Enrolment Type
By Specialist and/or Surgeon Referral

Mutation Status and Biomarker
Any or not stated

Is it a Cohort Trial?
No

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Discipline

Health Condition

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