NCT05190471

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

A Phase I/Ib Study of BP1002 (a Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Bio-Path Holdings, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Myeloid Leukemia, in Relapse
• Acute Myeloid Leukemia Refractory

Interventions

Type	Name	Description
DRUG	BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide	Dose escalation of BP1002 monotherapy
DRUG	Decitabine (in combination with BP1002)	Dose expansion of BP1002 in combination with decitabine

Timeline

• Start date: 2022-08-16
• Primary completion: 2027-03-01
• Completion: 2027-09-01
• First posted: 2022-01-13
• Last updated: 2025-03-10

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study