Actively Recruiting
A Phase 1/1b Open-Label Study to Evaluate Safety, Pharmacokinetics, and Preliminary Activity of BH-30236 in Adults With Relapsed or Refractory Acute Myelogenous Leukemia or Higher-Risk Myelodysplastic Syndrome
Led by BlossomHill Therapeutics · Updated on 2025-09-24
170
Participants Needed
13
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying BH-30236, a new oral drug, in adults with relapsed or refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome (HR-MDS). This Phase 1/1b, open-label trial aims to assess the safety, tolerability, how the body processes the drug (pharmacokinetics and pharmacodynamics), and preliminary anti-leukemic effects. The study is sponsored by BlossomHill Therapeutics and involves participants who have had 1 to 5 prior treatments and meet specific health criteria. The trial includes three parts: Phase 1 Part 1 tests BH-30236 alone in ascending doses to identify safe dosage levels. Phase 1 Part 2 evaluates BH-30236 combined with venetoclax, another oral drug, also in increasing doses. The Phase 1b Dose Expansion enrolls participants to further study the safety and early effectiveness of BH-30236 alone or with venetoclax at selected dose levels from earlier phases. Participants will take BH-30236 tablets orally at assigned dose levels, with venetoclax tablets added in combination groups. Safety is closely monitored through treatment-related adverse events and dose-limiting toxicities during the first 28-day cycle. Researchers will also assess remission rates and other measures of anti-leukemic activity for up to approximately one year. The study tracks drug blood levels, response duration, time to remission, and changes in RNA markers to understand treatment impact and tolerability.
CONDITIONS
Brief 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 or older
- Diagnosed with relapsed/refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome (HR-MDS) with at least 5% bone marrow blasts at inclusion
- Have received 1 to 5 prior lines of therapy
- ECOG performance status of 0 to 2
- Adequate liver function: AST and ALT ≤ 2.5 times the upper limit of normal (ULN), or ≤ 5 times ULN if liver involvement by AML or MDS; total bilirubin ≤ 1.5 times ULN without Gilbert's disease
- Adequate kidney function: creatinine clearance ≥ 60 mL/min (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
- Active and uncontrolled infections
- Unresolved adverse events greater than Grade from previous therapies
- History of other active malignancies except certain exceptions
- Prior treatment with a CDC-like kinase (CLK) inhibitor
- Acute or chronic graft versus host disease requiring systemic therapy within 4 weeks before study drug administration, except topical steroids or prednisone ≤ 20 mg daily
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive BH-30236 as a monotherapy or in combination with venetoclax to evaluate safety, tolerability, and preliminary anti-leukemic activity. Dosing follows a dose escalation design to determine recommended dose levels.
1 visit per cycle (in-person)
Duration - Up to 1 year
Participants are monitored for safety and response for up to approximately 1 year after starting treatment.
Regular visits depending on response and safety assessments
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
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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