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 (Jun 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
Treatments studied
Targeted therapy
Other
Cancer type
Acute Myeloid Leukemia
Chronic Myeloid 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 →Frequently asked questions
Is NCT06501196 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic hematopoietic stem cell transplant, donor lymphocyte infusion, CLK inhibitor disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify