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NCT06501196RecruitingPhase 1

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)

Source: ClinicalTrials.gov · Last updated 24 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
170 (estimated)
First submitted
17 Jun 2024
Start date
19 Jun 2024
Primary completion date
Jun 2026
Lead sponsor
BlossomHill Therapeutics
NCT number
NCT06501196

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 170
  • From 19 Jun 2024 to the primary completion date, Jun 2026
  • 13 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Unresolved AEs greater than Grade from prior therapies.
  • 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.

Other illness

  • Active and uncontrolled infections.
  • History of other active malignancy (with certain exceptions)

Lab values

  • Prior allogeneic HSCT within 3 months or donor lymphocyte infusion within 30 days of start of therapy;

Other

  • Diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia with blast crisis.

Who the study is looking for

  • ≥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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Roswell Park Cancer Institute
Coordinator of this site? Confirm its status		BuffaloUnited StatesRecruiting
Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
Coordinator of this site? Confirm its status		ChicagoUnited StatesRecruiting
The Ohio State University Wexner Medical Center - James Cancer Hosp
Coordinator of this site? Confirm its status		ColumbusUnited StatesRecruiting
City of Hope Medical Center
Coordinator of this site? Confirm its status		DuarteUnited StatesRecruiting
The University of Texas M. D. Anderson Cancer Center
Coordinator of this site? Confirm its status		HoustonUnited StatesRecruiting
University of California, Los Angeles
Coordinator of this site? Confirm its status		Los AngelesUnited StatesRecruiting
University of Wisconsin Clinical Science Center
Coordinator of this site? Confirm its status		MadisonUnited StatesRecruiting
Sylvester Comprehensive Cancer Center*
Coordinator of this site? Confirm its status		MiamiUnited StatesRecruiting
Sarah Cannon Research Institute
Coordinator of this site? Confirm its status		NashvilleUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status		New YorkUnited StatesRecruiting
Stanford Cancer Center
Coordinator of this site? Confirm its status		Palo AltoUnited StatesRecruiting
Fred Hutchinson Cancer Center
Coordinator of this site? Confirm its status		SeattleUnited StatesRecruiting
Moffitt Cancer Center
Coordinator of this site? Confirm its status		TampaUnited StatesRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.