A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors

  • Cancer
  • Solid Tumors
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Recruiting

This study runs in
Countries
  • Australia
  • United States
Study Identifier:

NCT06619587 GO45416

      Show study locations

      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 study 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

      Study Summary

      This is a first-in-human Phase I/II, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT06619587, GO45416 Study Identifier
      Phase I Arm A, Phase I Arm B Treatments
      Solid Tumor Condition
      Official Title

      A Phase I/II Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors With a KRAS G12D Mutation

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation
      • Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm
      Exclusion Criteria
      • Malabsorption or other condition that would interfere with enteral absorption
      • Active brain metastases
      • Clinically significant cardiovascular dysfunction or liver disease

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

       

      Related Studies

      Use our search to find other studies on ForPatients in related disease areas.

      Solid Tumors

      Clinical Research Explained

      Information about what clinical studies and observational studies are. Understand why you might want to take part in clinical research and why diversity in clinical research is important.

      Find out now