MasterKey-01: A Phase 1/2 Open-label Two-part Multicenter Study to Assess the Safety Tolerability Pharmacokinetics and Antitumor Activity of BDTX-189 an Inhibitor of Allosteric ErbB Mutations in Patients with Advanced Solid Malignancies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Advanced Solid Malignancies
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Histologically- or cytologically-confirmed locally advanced or metastatic solid tumor with documented recurrence or disease progression (PD) from standard anticancer therapy in the advanced/metastatic setting. 2) No standard therapy available or standard therapy is considered unsuitable or intolerable according to the Investigator and consultation with the Medical Monitor. 3) For Part A: Patients with a solid tumor with alterations that may be associated with antitumor activity based on preclinical data for BDTX-189 such as: a. Allosteric HER2 or HER3 mutation(s) (see Appendix I) b. EGFR or HER2 exon 20 insertion mutation (see Appendix I) c. HER2 amplified or overexpressing tumor d. EGFR exon 19 deletion or L858R mutation 4) For Part B: Patients with a solid tumor harboring an: a. Allosteric HER2 mutation b. EGFR or HER2 exon 20 insertion mutation

You may not be eligible for this study if the following are true:

  • 1) Significant cardiovascular disease. 2) Leptomeningeal or untreated and/or symptomatic central nervous system (CNS) malignancies (primary or metastatic). Patients with asymptomatic CNS metastases who have undergone surgery or radiotherapy and who have been on a stable or tapering dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial. 3) Known tumor-harboring resistance mutations including EGFR T790M or C797S mutations or HER2 C805S mutation.


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