A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
A Phase 1/1b Open-Label, Dose Escalation, First-in- Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-leukemic Activity of the Orally Available CDC-Like Kinase (CLK) Inhibitor, BH-30236, in Adults With Relapsed or Refractory Acute Myelogenous Leukemia (R/R AML) or Higher-Risk Myelodysplastic Syndrome (HR-MDS)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion 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 at time of inclusion. * Prior treatment history must include 1-5 prior lines of therapy. * ECOG performance status ≤2. * Adequate organ function evidenced by the following laboratory values: * Hepatic: Transaminase levels aspartate aminotransferase \[AST\]/ alanine transaminase \[ALT\] ≤ 2.5 × upper limit of normal (ULN). In cases of liver involvement by AML or MDS, AST and ALT \< 5.0 × ULN is acceptable. Total bilirubin ≤ 1.5 × ULN in the absence of documented Gilbert's disease. * Renal: Measured or calculated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula) The above are a summary, other inclusion criteria details may apply. Exclusion Criteria: * Diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia with blast crisis. * Prior allogeneic HSCT within 3 months or donor lymphocyte infusion within 30 days of start of therapy; * Active and uncontrolled infections. * Unresolved AEs greater than Grade from prior therapies. * History of other active malignancy (with certain exceptions) * Prior treatment with a CLK inhibitor. * Any acute or chronic graft versus host disease requiring systemic therapy within 4 weeks prior to study drug administration with the exception of topical steroids or the equivalent of 20 mg of prednisone or less. The above is a summary, other exclusion criteria details may apply.
About the study
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 safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered as a combination therapy with venetoclax. Approximately 48 participants may be enrolled in Phase 1, Part 2 Dose Escalation - Combination with Venetoclax.
Phase 1b (Dose Expansion) will follow Phase 1 to further understand the relationships among dose, exposure, toxicity, tolerability, and clinical activity. Up to 72 participants may be enrolled in Phase 1b of the study as a monotherapy or in combination with venetoclax.
What is being tested
- BH-30236 (drug)
- Venetoclax (drug)
Sponsor: BlossomHill Therapeutics · Participants: 170 · Started: Jun 19, 2024
Contact the study team
- Sponsor Contact · Phone: (858) 732-3880
Official record on ClinicalTrials.gov — NCT06501196
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.