A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
Public ClinicalTrials.gov record NCT06501196. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06501196
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 170 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 18, 2024
- Primary completion
- May 31, 2026
- Completion
- May 31, 2027
- Last update posted
- Sep 23, 2025
2024 – 2027
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | Recruiting |
| University of California Los Angeles | Los Angeles | California | 90095 | Recruiting |
| Stanford Cancer Center | Palo Alto | California | 94304 | Recruiting |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | 33612 | Recruiting |
| Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion | Chicago | Illinois | 60611 | Recruiting |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Recruiting |
| The Ohio State University Wexner Medical Center - James Cancer Hosp | Columbus | Ohio | 43210 | Recruiting |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | Recruiting |
| The University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | Recruiting |
| University of Wisconsin Clinical Science Center | Madison | Wisconsin | 53792 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06501196, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 23, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06501196 live on ClinicalTrials.gov.