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

Colorectal Cancer Clinical Trial

Official title:
A Phase 1, Open-label Study of Oral BDTX-4933 in Patients With KRAS, BRAF and Other Select RAS/MAPK Mutation Positive Neoplasms

Clinical Trial Summary

BDTX-4933-101 is a first-in-human, open-label, Phase 1 dose escalation and an expansion cohort study designed to evaluate the safety and tolerability, maximum tolerated dose (MTD) and the preliminary recommended Phase 2 dose (RP2D), and antitumor activity of BDTX-4933. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced/metastatic non-small cell lung cancer (NSCLC) harboring KRAS non-G12C mutations or BRAF mutations, advanced/metastatic melanoma harboring BRAF or NRAS mutations, histiocytic neoplasms harboring BRAF or NRAS mutations, and other solid tumors harboring BRAF mutations. The study population for the Dose Expansion part of the study comprises adults with recurrent advanced/metastatic NSCLC harboring KRAS non-G12C mutations. All patients will self-administer BDTX-4933 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • BRAF Gene Mutation
  • BRAF Mutation-Related Tumors
  • BRAF V600 Mutation
  • BRAF V600E
  • Brain Metastases
  • Brain Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Cancer
  • Colorectal Carcinoma
  • Colorectal Neoplasms
  • Histiocytosis
  • KRAS G12D
  • KRAS Mutation-Related Tumors
  • Lung Neoplasms
  • Melanoma
  • Melanoma (Skin)
  • Metastatic Lung Cancer
  • Metastatic Lung Non-Small Cell Carcinoma
  • Metastatic Melanoma
  • Neoplasms
  • Non-small Cell Lung Cancer
  • NRAS Gene Mutation
  • NSCLC
  • Recurrence
  • Recurrent Histiocytic and Dendritic Cell Neoplasm
  • Recurrent Lung Cancer
  • Recurrent Lung Non-Small Cell Carcinoma
  • Recurrent Melanoma
  • Recurrent NSCLC
  • Solid Carcinoma
  • Solid Tumor
  • Thyroid Cancer
  • Thyroid Carcinoma
  • Thyroid Diseases
  • Thyroid Neoplasms
Clinical Trial Details
NCT number NCT05786924
Study type Interventional
Source Black Diamond Therapeutics, Inc.
Contact BDTX Clinical Trial Navigation Service
Phone (866) 955-4397
Email blackdiamondtx@careboxhealth.com
Status Recruiting
Phase Phase 1
Start date April 18, 2023
Completion date December 2026
View Details
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