A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome

Study BH-30236-01 is a first-in-human (FIH), Phase 1/1b, open-label, dose escalation and expansion study in participants with relapsed/refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome (HR-MDS). Phase 1, Part 1 Dose Escalation - Monotherapy will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered orally. Approximately 50 participants may be enrolled in Phase 1, Part 1 Dose Escalation - Monotherapy. Phase 1, Part 2 Dose Escalation - Combination with Venetoclax will evaluate the

Trial Details

NCT ID
NCT06501196
Phase
PHASE1
Sponsor
BlossomHill Therapeutics
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • BH-30236
  • Venetoclax
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Los Angeles, California, United States|34.05223,-118.24368
  • Palo Alto, California, United States|37.44188,-122.14302
  • Miami, Florida, United States|25.77427,-80.19366
  • Tampa, Florida, United States|27.94752,-82.45843

Key Eligibility Criteria

  • ≥18 years.
  • Diagnosis of relapsed/refractory acute myelogenous leukemia (R/R) AML or higher-risk myelodysplastic syndrome (HR-MDS) with ≥5% bone marrow blast a…
  • Prior treatment history must include 1-5 prior lines of therapy.
  • ECOG performance status ≤2.

For full eligibility, visit ClinicalTrials.gov.

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