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RecruitingLast updated: 7 February 2024

This phase I trial is trying to understand if a new oral drug works and is safe for the treatment of advanced KRAS G12C mutated solid cancers that have spread to other parts of the bodyA Phase I Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

Clinical summary

Summary

This is a Dose-escalation (Stage I) and Dose expansion (Stage II) trial. Participants eligible for Stage I will receive oral GDC-6036 once daily (PO QD). The dose will be increased in successive cohorts until a safety threshold is observed. Participants with select solid tumours will eligible for Stage II and treated with oral GDC-6036 once daily at a recommended dose.

Conditions

This trial is treating patients with non-small cell lung cancer, colorectal cancer and other cancers with a KRAS G12C mutation.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Genetech, Inc.

Scientific Title

A Phase I Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

Eligibility

Inclusion

  • 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

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

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

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