drugset / Trial / NCT05190471

A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)

NCT05190471

Phase 1 Recruiting 48 enrolled Bio-Path Holdings, Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

This study evaluates the safety and tolerability of escalating doses of BP1002 (Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in patients with refractory/relapsed AML. The study is designed to assess the safety profile, identify DLTs, biologically effective doses, PK, PD and potential anti-leukemic effects of BP1002 as single agent (dose escalation phase) followed by assessing BP1002 in combination with decitabine (dose expansion phase).

Timeline

Start
2022-08-16
Primary completion
2027-03
Completion
2027-09

Drugs

EvaluationDrugModalityDoseRoute
Subject BP1002 Antisense oligonucleotide
Background Decitabine Small molecule