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

Brief description of study

The purpose of the study is to determine the recommended phase two dose and dosing schedule of BDTX-189, as a single agent administered orally to adult patients with advanced solid malignancies. In the study, we also want to know the safety and efficacy of the study drug BDTX-189. The study drug BDTX-189 is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.


Clinical Study Identifier: s20-01525
ClinicalTrials.gov Identifier: NCT04209465
Principal Investigator: Elaine Shum.


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