A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome

Recruiting now · Phase 1

Conditions studied: Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Preleukemia, Myelodysplastic Syndromes, Refractory Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT06501196

Run by

BlossomHill Therapeutics

People needed

170

Starts

2024-06-19

Expected to finish

2027-06-01

Last updated by the study team

2025-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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.

You may not qualify if…

• 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.

Where it is running

• City of Hope Medical Center — Duarte, California, United States (enrolling)
• University of California Los Angeles — Los Angeles, California, United States (enrolling)
• Stanford Cancer Center — Palo Alto, California, United States (enrolling)
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion — Chicago, Illinois, United States (enrolling)
• Roswell Park Cancer Institute — Buffalo, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• The Ohio State University Wexner Medical Center - James Cancer Hosp — Columbus, Ohio, United States (enrolling)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
• The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• University of Wisconsin Clinical Science Center — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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