Recruiting
Phase 1

BH-30236

Sponsor:

BlossomHill Therapeutics

Code:

NCT06501196

Conditions

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BH-30236

Venetoclax

Study Details

Brief 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.

Conditions

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Study ID

NCT06501196

Start date

Jun 19, 2024

Status verified date

Sep, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

170 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation Cohort - Monotherapy

BH-30236 Monotherapy for Dose Escalation

experimental: Dose Escalation Cohort - Combination with Venetoclax

BH-30236 in Combination with Venetoclax for Dose Escalation.

experimental: Dose Expansion Cohort - Monotherapy

BH-30236 based on Monotherapy dose escalation data.

experimental: Dose Expansion Cohort - Combination with Venetoclax

BH-30236 in Combination with Venetoclax based on Dose Escalation data

Interventions

BH-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.

Venetoclax

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

Primary outcome measure

  • Dose Escalation: Frequency of dose limiting toxicities (DLTs) [ Time Frame: Dose-limiting toxicities are collected during the first treatment cycle (28 days) ]
  • Dose Escalation and Expansion: Safety evaluation of BH-30236: Number of participants with treatment-related adverse events as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [ Time Frame: From first dose until 28 days after last dose of BH-30236 ]
  • Dose Expansion: Composite Complete Remission (CR) Rate [ Time Frame: From first dose of BH-30236 until disease progression (up to approximately 1 year) ]

Central Contacts and Locations

Central contacts

Sponsor Contact

(858) 732-3880clinicaltrials@bhtherapeutics.com

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Stanford Cancer Center

Recruiting

Palo Alto, California, United States, 94304

Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion

Recruiting

Chicago, Illinois, United States, 60611

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

The Ohio State University Wexner Medical Center - James Cancer Hosp

Recruiting

Columbus, Ohio, United States, 43210

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

The University of Texas M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

University of Wisconsin Clinical Science Center

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

BlossomHill Therapeutics

Last update posted

Sep 24, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by BlossomHill Therapeutics on 2025-09-24.