Condition: Leukemia · Leukemia, Myeloid · Leukemia, Myeloid, Acute · Sponsor: BlossomHill Therapeutics
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.
This description comes directly from the study's public registry record.
Sponsor Contact · (858) 732-3880 · clinicaltrials@bhtherapeutics.com
Always discuss trial participation with your own doctor first.
| City of Hope Medical Center | Duarte, California, United States | Recruiting |
| University of California Los Angeles | Los Angeles, California, United States | Recruiting |
| Stanford Cancer Center | Palo Alto, California, United States | Recruiting |
| Sylvester Comprehensive Cancer Center | Miami, Florida, United States | Recruiting |
| Moffitt Cancer Center | Tampa, Florida, United States | Recruiting |
| Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion | Chicago, Illinois, United States | Recruiting |
| Roswell Park Cancer Institute | Buffalo, New York, United States | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York, New York, United States | Recruiting |
| The Ohio State University Wexner Medical Center - James Cancer Hosp | Columbus, Ohio, United States | Recruiting |
| Sarah Cannon Research Institute | Nashville, Tennessee, United States | Recruiting |
| The University of Texas M.D. Anderson Cancer Center | Houston, Texas, United States | Recruiting |
| Fred Hutchinson Cancer Center | Seattle, Washington, United States | Recruiting |
+ 1 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06501196