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Clinical Trial Details
A Study of BDTX-4933 in Patients With BRAF and Select RAS/?MAPK Mutation-Positive Cancers
Complete Title: A Phase 1, Open-label Study of Oral BDTX-4933 in Patients with BRAF and Other Select RAS/MAPK Mutation Positive Neoplasms
Trial Phase: I
Investigator: Sylvia Lee
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.
Keywords:
- Brain Cancer
- Histiocytosis
- Melanoma
- Solid Tumors
- Thyroid Cancer
- Lung Carcinoma, Non-Small-Cell (NSCLC)
- Colorectal Neoplasms
- Metastatic Solid Tumors
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Adult
I
Sylvia Lee
RG1123571
NCT05786924
A Phase 1, Open-label Study of Oral BDTX-4933 in Patients with BRAF and Other Select RAS/MAPK Mutation Positive Neoplasms
Brain Cancer
Histiocytosis
Melanoma
Solid Tumors
Thyroid Cancer
Lung Carcinoma, Non-Small-Cell (NSCLC)
Colorectal Neoplasms
Metastatic Solid Tumors