Clinical Trial

PBSS1113 in Combination With Azacitidine to Treat Patients With AML/MDS

Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) are highly heterogeneous myeloid malignancies where few effective targeted therapies are available. While venetoclax has significantly advanced the treatment landscape, therapeutic resistance remains a critical challenge. Consequently, patients with relapsed or refractory (R/R) AML/MDS face a profound unmet medical need for novel therapeutic options. PBSS1113 has demonstrated robust anti-leukemic activity in both in vitro and in vivo models, alongside an acceptable safety profile in a Phase I study. This Phase Ib/II trial will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of PBSS1113 in combination with azacitidine for treatment-naive unfit AML, R/R AML, and higher-risk MDS populations.
Trial Details
NCT Number NCT07761533
Lead Sponsor Chaser Therapeutics, Inc.
Conditions Acute Myeloid Leukemia (AML), MDS (Myelodysplastic Syndrome)
Enrollment 29 participants
Start Date 2025-09-08
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-14