An official website of the United States government
A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
Trial Status: active
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.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT06501196.
