Testing BH-30236 for relapsed or refractory acute myelogenous leukemia and higher-risk myelodysplastic syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of BH-30236, a CLK inhibitor, in adults with relapsed or refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome (HR-MDS). The study is divided into two phases: Phase 1 focuses on dose escalation to determine the maximum tolerated dose and preliminary efficacy, while Phase 1b involves dose expansion to further assess safety and anti-leukemic activity at the recommended doses. Approximately 74 participants will be enrolled across both phases, with careful monitoring of pharmacokinetics and pharmacodynamics.

Why it matters

Who can join: the full rules

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.

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting
• University of California Los Angeles
  Los Angeles, California, United States Recruiting
• Stanford Cancer Center
  Palo Alto, California, United States Recruiting
• Sylvester Comprehensive Cancer Center
  Miami, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Sponsor Contact
• Email: clinicaltrials@bhtherapeutics.com
• Phone: (858) 732-3880

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.