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

NCT05190471 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-03-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Bio-Path Holdings, Inc.

    lead INDUSTRY

Principal Investigators

  • Gail J Roboz, MD · Weill Cornell Medical College - New York-Presbyterian Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-16
Primary Completion
2027-03-31
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05190471 on ClinicalTrials.gov