OncoMatch/Clinical Trials/NCT06501196
A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
Is NCT06501196 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including BH-30236 and Venetoclax for leukemia.
Treatment: BH-30236 · Venetoclax — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: allogeneic hematopoietic stem cell transplant
Exception: allowed if >3 months prior to start of therapy
Prior allogeneic HSCT within 3 months
Cannot have received: donor lymphocyte infusion
Exception: allowed if >30 days prior to start of therapy
donor lymphocyte infusion within 30 days of start of therapy
Cannot have received: CLK inhibitor
Prior treatment with a CLK inhibitor
Lab requirements
Kidney function
creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula)
Liver function
AST/ALT ≤ 2.5 × ULN (or <5.0 × ULN if liver involvement by AML or MDS); total bilirubin ≤ 1.5 × ULN in absence of Gilbert's disease
Hepatic: AST/ALT ≤ 2.5 × ULN (or <5.0 × ULN if liver involvement by AML or MDS); total bilirubin ≤ 1.5 × ULN in absence of Gilbert's disease. Renal: creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
- University of California Los Angeles · Los Angeles, California
- Stanford Cancer Center · Palo Alto, California
- Sylvester Comprehensive Cancer Center · Miami, Florida
- Moffitt Cancer Center · Tampa, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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