Status:
RECRUITING
A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
Lead Sponsor:
BlossomHill Therapeutics
Conditions:
Leukemia
Leukemia, Myeloid
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 my...
Detailed Description
This is a Phase 1/1b, multi-center, open-label, dose escalation, first-in-human study to evaluate the safety, tolerability, PK, PD, and preliminary anti-leukemic activity of the CLK inhibitor, BH-3023...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06501196
Start Date
June 19 2024
End Date
June 1 2027
Last Update
September 24 2025
Active Locations (13)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
University of California Los Angeles
Los Angeles, California, United States, 90095
3
Stanford Cancer Center
Palo Alto, California, United States, 94304
4
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136