Fred Hutchinson Cancer Research Center | Seattle, WA
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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, BRAF, or CRAF (RAF1) mutations, advanced/metastatic melanoma harboring BRAF or NRAS mutations, histiocytic neoplasms harboring BRAF, CRAF, 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.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Disease criteria:
Histologically or cytologically confirmed recurrent/advanced (unresectable) or metastatic solid tumors or histiocytic neoplasms with documented RAS or BRAF mutations.
Note: Patients may have stable central nervous system (CNS) metastases. Patients with active CNS metastases or primary CNS tumors associated with progressive neurological symptoms or needing increased doses of corticosteroids to control the CNS disease are excluded from the study.
Dose Escalation cohorts:
Dose Expansion cohort:
Recurrent advanced/metastatic NSCLC with KRAS non-G12C mutations without small cell lung cancer transformation with progressive disease confirmed by radiographic assessment.
Prior standard-of-care
For dose levels <200 mg once daily and/or not at preliminary RP2D(s):
For dose levels ≥200 mg once daily or at preliminary RP2D(s):
a. Patients must have received at least 1 but no more than 2 prior lines of systemic therapy for metastatic/advanced disease (adjuvant and maintenance therapy do not count towards the limit).
Evaluable or measurable disease in dose escalation and measurable disease only for dose expansion cohorts.
Adequate bone marrow and organ function.
Recovered from toxicity to prior anti-cancer therapy.
Appropriate candidate for BDTX-4933 monotherapy.
Life expectancy of >=12 weeks in the opinion of the Investigator.
Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups
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BDTX Clinical Trial Navigation Service
Data sourced from clinicaltrials.gov
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