A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

  • Cancer
  • Solid Tumors
  • Advanced Solid Tumors
  • Lung Cancer
  • Non-Small Cell Lung Cancer (NSCLC)
  • Colorectal Cancer (CRC)
  • Non Small Cell Lung Carcinoma
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Recruiting

This trial runs in
Countries
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Germany
  • Hungary
  • Israel
  • Italy
  • Kenya
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • United Kingdom
  • United States
Trial Identifier:

NCT04449874 2020-000084-22 2023-506311-18-00 GO42144

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial 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.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT04449874, GO42144, 2020-000084-22, 2023-506311-18-00 Trial Identifier
      GDC-6036, Atezolizumab, Cetuximab, Bevacizumab, Erlotinib, GDC-1971, Inavolisib Treatments
      Non-Small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumors Condition
      Official 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

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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.

      For the latest version of this information please go to www.forpatients.roche.com

       

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