A Phase 1 Study of BH-30236 in People With Acute Myelogenous Leukemia or Higher-Risk Myelodysplastic Syndrome

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Full Title

A Phase 1/1b Open-Label, Dose Escalation, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-leukemic Activity of the Orally Available CDC-Like Kinase (CLK) Inhibitor, BH-30236, in Adults with Relapsed or Refractory Acute Myelogenous Leukemia (R/R AML) or Higher-Risk Myelodysplastic Syndrome (HR-MDS)

Purpose

Researchers want to find the best dose of BH-30236 to treat people with leukemia. This study includes people with acute myelogenous leukemia (AML) that relapsed (came back) after treatment. It also includes people with higher-risk myelodysplastic syndrome (MDS). Higher-risk means a disease has a higher chance of coming back or not responding to standard treatment.

BH-30236 blocks proteins called CLK that may be abnormal in cancer cells. CLK proteins are important for controlling cell growth and survival. By blocking these proteins, BH-30236 may help slow or stop the growth of your cancer. It is taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have relapsed AML or higher-risk MDS that has been treated with at least 1 regimen of therapy.
  • Have completed prior anti-cancer treatments at least 2 weeks before taking BH-30236.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Eytan Stein’s office at 646-608-3749.

Protocol

24-209

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06501196