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Trial Title:
A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
NCT ID:
NCT06501196
Condition:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Refractory Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid, Acute
Preleukemia
Leukemia, Myeloid
Myelodysplastic Syndromes
Syndrome
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BH-30236
Description:
BH-30236 will be provided as either a 5 or 30 mg tablet. Patients will take BH-30236
orally depending on their dose level assignment.
Arm group label:
Dose Escalation Cohort
Arm group label:
Dose Expansion Cohort
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 (Dose Escalation) 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 of the study.
Phase 1b (Dose Expansion) will follow Phase 1 to further understand the relationships
among dose, exposure, toxicity, tolerability, and clinical activity. Up to 24
participants may be enrolled in Phase 1b of the study.
The dose expansion part (Phase 1b) will be followed to understand the relationships among
dose, exposure, toxicity, tolerability and clinical activity. Up to 24 participants may
be enrolled in Phase 1b of the study.
Detailed description:
This is a Phase 1/1b, multi-center, open-label, dose escalation, first-in-human study to
evaluate the safety, tolerability, PK, PD, and preliminary anti-leukemic activity of the
CLK inhibitor, BH-30236, in adult subjects with R/R AML or HR-MDS.
The study consists of two parts: Phase 1 Dose Escalation and Phase 1b Dose Expansion.
Phase 1 Dose Escalation is anticipated to enroll approximately 50 subjects to evaluate
the safety, tolerability, PK, PD, and preliminary anti-leukemic activity of BH-30236, as
well as determine the MTD and/or the preliminary recommended dose(s) for expansion
(RDEs).
Phase 1 will follow an accelerated 3 + 3 dose escalation, where participants will receive
ascending doses of BH-30236 to determine the recommended RDEs.
Phase 1b Dose Expansion will enroll approximately 24 subjects to evaluate the safety,
tolerability, and preliminary anti-leukemic activity of BH-30236 at selected RDEs
determined in Phase 1 Dose Escalation.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Start date:
June 19, 2024
Completion date:
June 2027
Lead sponsor:
Agency:
BlossomHill Therapeutics
Agency class:
Industry
Source:
BlossomHill Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06501196
