Actively Recruiting
A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
Led by BlossomHill Therapeutics · Updated on 2025-09-24
170
Participants Needed
13
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosis of relapsed/refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome (HR-MDS) with at least 5% bone marrow blasts at inclusion
- Prior treatment with 1 to 5 lines of therapy
- ECOG performance status of 2 or less
- Adequate liver function: AST and ALT no more than 2.5 times upper limit of normal (ULN), or less than 5 times ULN if liver involved by AML or MDS; total bilirubin no more than 1.5 times ULN without Gilbert's disease
- Adequate kidney function: creatinine clearance of 60 mL/min or higher (Cockcroft-Gault formula)
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia with blast crisis
- Prior allogeneic hematopoietic stem cell transplant within 3 months or donor lymphocyte infusion within 30 days before therapy start
- Active and uncontrolled infections
- Unresolved adverse events greater than Grade 1 from prior treatments
- History of other active cancers except certain allowed types
- Prior treatment with a CLK inhibitor
- Any acute or chronic graft versus host disease requiring systemic therapy within 4 weeks before study drug, except topical steroids or prednisone equivalent of 20 mg or less
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
University of California Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
3
Stanford Cancer Center
Palo Alto, California, United States, 94304
Actively Recruiting
4
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
5
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
6
Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
Chicago, Illinois, United States, 60611
Actively Recruiting
7
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
9
The Ohio State University Wexner Medical Center - James Cancer Hosp
Columbus, Ohio, United States, 43210
Actively Recruiting
10
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
11
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
12
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
13
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
S
Sponsor Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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