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) BH-30236
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What's the purpose of this trial?

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).

This trial is currently open and accepting patients.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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.

Additional Trial Information

Phase 1

Enrollment: 170 patients (estimated)

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Trial Locations

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California

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

UCLA Medical Center of Hematology/Oncology

Los Angeles, CA

Open and Accepting

Stanford Univ Med Ctr. / Lucile Packard Children's Hosp

Palo Alto, CA

Open and Accepting

Florida

Sylvester Comprehensive Cancer Center (Main) University of Miami Health System

Miami, FL

Open and Accepting

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Open and Accepting

Illinois

Robert H. Lurie Comprehensive Cancer Center Northwestern University Feinberg School of Medicine

Chicago, IL

Open and Accepting

New Jersey

Memorial Sloan Kettering Basking Ridge

Basking Ridge, NJ

Open and Accepting

Memorial Sloan Kettering Monmouth

Middletown, NJ

Open and Accepting

Memorial Sloan Kettering Bergen

Montvale, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Roswell Park Cancer Institute

Buffalo, NY

Open and Accepting

Memorial Sloan Kettering Nassau

Uniondale, NY

Open and Accepting

Memorial Sloan Kettering Westchester

West Harrison, NY

Open and Accepting

Ohio

Ohio State University Comprehensive Cancer Center James Cancer Hospital and Solove Research Institute

Columbus, OH

Open and Accepting

Tennessee

Sarah Cannon Research Institute TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

Washington

Fred Hutchinson Cancer Research Center University of Washington Cancer Consortium / SCCA

Seattle, WA

Open and Accepting

Wisconsin

University of Wisconsin - Carbone Cancer Center University of Wisconsin Health

Madison, WI

Open and Accepting
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