A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome

Phase 1

Recruiting

• Conditions: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Refractory Acute Myeloid Leukemia

• Registration Number: NCT06501196
• Lead Sponsor: BlossomHill Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-6-17
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

<br><br> - =18 years.<br><br> - Diagnosis of relapsed/refractory acute myelogenous leukemia (R/R) AML or higher-risk<br> myelodysplastic syndrome (HR-MDS) with =5% bone marrow blast at time of inclusion.<br><br> - Prior treatment history must include 1-5 prior lines of therapy.<br><br> - ECOG performance status =2.<br><br> - Adequate organ function evidenced by the following laboratory values:<br><br> - Hepatic: Transaminase levels aspartate aminotransferase [AST]/ alanine transaminase<br> [ALT] = 2.5 × upper limit of normal (ULN). In cases of liver involvement by AML or<br> MDS, AST and ALT < 5.0 × ULN is acceptable. Total bilirubin = 1.5 × ULN in the<br> absence of documented Gilbert's disease.<br><br> - Renal: Measured or calculated creatinine clearance = 60 mL/min (Cockcroft-Gault<br> formula)<br><br>The above are a summary, other inclusion criteria details may apply.<br><br>Exclusion Criteria:<br><br> - Diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia with blast<br> crisis.<br><br> - Prior allogeneic HSCT within 3 months or donor lymphocyte infusion within 30 days of<br> start of therapy;<br><br> - Active and uncontrolled infections.<br><br> - Unresolved AEs greater than Grade from prior therapies.<br><br> - History of other active malignancy (with certain exceptions)<br><br> - Prior treatment with a CLK inhibitor.<br><br> - Any acute or chronic graft versus host disease requiring systemic therapy within 4<br> weeks prior to study drug administration with the exception of topical steroids or<br> the equivalent of 20 mg of prednisone or less.<br><br>The above is a summary, other exclusion criteria details may apply.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose Escalation: Frequency of dose limiting toxicities (DLTs);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;Dose Expansion: Composite Complete Remission (CR) Rate

Secondary Outcome Measures

Name	Time	Method
Dose Escalation and Expansion: Maximum observed blood concentration (Cmax) of BH-30236.;Dose Escalation: Area under the blood concentration time curve (AUC) of BH-30236.;Dose Escalation and Expansion: Concentration before dose at steady state (Ctrough).;Dose Escalation and Expansion: Objective Response Rate (ORR);Dose Escalation and Expansion: Duration of Response (DoR);Dose Escalation and Expansion: Time to remission (TTR);Dose Escalation and Expansion: Relapse-free Survival (RFS);Dose Escalation and Expansion: Measurable Residual Disease (MRD);Dose Escalation and Expansion: Measurement of the change in RNA alternative splicing markers on BH-30236 treatment;Dose Escalation and Expansion: Complete remission (CR) / complete remission with partial hematologic recovery (CRh) rate for AML and complete remission/partial remission (CR/PR) rate for HR-MDS