Active — Not RecruitingPhase 1

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

United States498 participantsStarted 2020-07-29

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Percentage of Participants With Adverse Events (AEs)

Timeframe: From Cycle 1 Day 1 until 28 days after the final dose (or as specified in the protocol). A cycle is 21 days.

Percentage of Participants With Dose-Limiting Toxicities (DLTs)

Timeframe: From Cycle 1 Day 1 through Day 21. A cycle is 21 days.

Trial details

NCT IDNCT04449874

SponsorGenentech, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

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