RecruitingLeukemiaLeukemia, MyeloidLeukemia, Myeloid, Acute

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

Eligible age

18+ yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

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About this study

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.

Sponsor: BlossomHill Therapeutics

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.