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Black Diamond trial of BDTX-4933

A Phase 1 Study of BDTX-4933 in Patients With BRAF and Select RAS/MAPK Mutation Positive Cancers


Brief Summary:

"BDTX-4933-101 is a first-in-human, open-label, Phase 1 dose escalation and multiple expansion cohort study designed to evaluate the safety and antitumor activity of BDTX-4933. The study population comprises adults with recurrent advanced/metastatic cancers harboring BRAF (Class I, II, and III), KRAS (other than G12C such as G12D, G12V), or NRAS mutations including non-small cell lung cancer (NSCLC), melanoma, histiocytic neoplasms, thyroid cancer, colorectal cancer, and other solid tumor cancers with or without brain metastases.

All patients will self-administer BDTX-4933 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.140 patients."


NOTE: All clinical trials involve risk; so please consult with your oncology team and ask questions of the trial researchers.


NCT05786924 Trial Listing


Recent change August 2024

Other mutations specifically being tagged in the trial as "Conditions"

KRAS G12D, KRAS G12V, KRAS G12A, KRAS G12F, KRAS G12R, KRAS G13D as well as "Acquired Resistance to KRAS G12C Inhibitor"


And referenced in the expansion cohort -

"NSCLC with KRAS non-G12C mutations, including other mutations at KRAS-G12 (eg, G12V/G12D) and other oncogenic variants of KRAS mutations on G13 and Q61 amino acid residues, BRAF, or CRAF mutations."



RESEARCH from BLACK DIAMOND THERAPEUTICS WEBSITE


34th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics


Oral, Brain-Penetrant Inhibitor of Oncogenic BRAF MasterKey Mutations



August 2024 Corporate Presentation slides 38 - 43

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