RecruitingPhase 1NCT06501196

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

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)


Sponsor

BlossomHill Therapeutics

Enrollment

170 participants

Start Date

Jun 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new experimental drug called BH-30236 in people with relapsed or treatment-resistant acute myeloid leukemia (AML) — a fast-growing blood cancer — or higher-risk myelodysplastic syndrome (MDS), a bone marrow disorder that can turn into leukemia. **You may be eligible if...** - You are 18 or older - You have been diagnosed with relapsed/refractory AML or higher-risk MDS with at least 5% abnormal cells in your bone marrow - You have received 1 to 5 prior lines of treatment - You have reasonable overall health (ECOG score of 2 or lower) - Your liver and kidney functions are within acceptable ranges **You may NOT be eligible if...** - You have a specific type of AML called acute promyelocytic leukemia, or CML in blast crisis - You received a bone marrow/stem cell transplant from a donor within the past 3 months - You have an active, uncontrolled infection - You have unresolved serious side effects from prior treatments - You have another active cancer - You have previously been treated with a CLK inhibitor - You have active graft-versus-host disease (GVHD) requiring strong medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBH-30236

BH-30236 will be provided as either a 5 mg, 15 mg or 30 mg tablet. Participants will take BH-30236 tablets orally depending on their dose level assignment.

DRUGVenetoclax

Venetoclax will be provided as 10 mg, 50 mg or 100 mg tablets. Participants will take venetoclax orally per label instructions.


Locations(13)

City of Hope Medical Center

Duarte, California, United States

University of California Los Angeles

Los Angeles, California, United States

Stanford Cancer Center

Palo Alto, California, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion

Chicago, Illinois, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

The Ohio State University Wexner Medical Center - James Cancer Hosp

Columbus, Ohio, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

University of Wisconsin Clinical Science Center

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06501196


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