RecruitingPhase 1NCT05190471

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)


Sponsor

Bio-Path Holdings, Inc.

Enrollment

48 participants

Start Date

Aug 16, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called BP1002 in adults with relapsed or treatment-resistant acute myeloid leukemia (AML) who have no remaining effective options. BP1002 works by targeting a protein that helps cancer cells survive. **You may be eligible if...** - You are 18 or older with AML that has come back or failed to respond to available treatments - You are in reasonably good health (ECOG 0–2) - Your liver and kidney function are within acceptable ranges - You are willing to use effective contraception during and after treatment **You may NOT be eligible if...** - You have acute promyelocytic leukemia (APL) or chronic myeloid leukemia - You have leukemia that has spread to the brain and requires direct spinal treatment - You have recently received cancer treatment (within 14 days) - You are pregnant or breastfeeding - You have had a heart attack, stroke, or severe heart disease within the past 6 months - You have uncontrolled seizures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide

Dose escalation of BP1002 monotherapy

DRUGDecitabine (in combination with BP1002)

Dose expansion of BP1002 in combination with decitabine


Locations(4)

Scripps Green Hospital

La Jolla, California, United States

UCLA Medical Center

Los Angeles, California, United States

Weill Cornell Medical College - NewYork-Presbyterian Hospital

New York, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05190471


Related Trials