Actively Recruiting
A Phase I/Ib Study of BP1002 (a Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)
Led by Bio-Path Holdings, Inc. · Updated on 2025-03-10
48
Participants Needed
4
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying BP1002, a liposomal Bcl-2 antisense oligodeoxynucleotide, to evaluate its safety, tolerability, and potential effects in patients with refractory or relapsed acute myeloid leukemia (AML). This Phase I/Ib study aims to find dose-limiting toxicities, biologically effective doses, pharmacokinetics, pharmacodynamics, and possible anti-leukemic activity of BP1002 alone and in combination with decitabine. The study is sponsored by Bio-Path Holdings, Inc. The study has two parts: a dose escalation phase where BP1002 is given alone at increasing doses, and a dose expansion phase where BP1002 is combined with decitabine. The dose escalation part evaluates BP1002 monotherapy, while the expansion part assesses the combination treatment. Participants receive the study drugs according to these protocols to determine safety and effective dose recommendations. Participants will undergo regular assessments including blood and bone marrow tests to monitor treatment effects and safety. Researchers will track adverse events, laboratory results, heart rhythms, drug levels in the blood, and immune responses. The study will also evaluate leukemia response indicators and survival outcomes over time. The total participation includes follow-up periods to monitor safety and treatment effects, lasting up to several months.
CONDITIONS
Brief Title
A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older with histologic evidence of refractory or relapsed AML who have failed available active treatments
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- For dose expansion phase, documented AML diagnosis and eligibility for decitabine therapy
- Adequate liver function with AST and ALT less than or equal to 2.5 times the upper limit of normal
- Total bilirubin usually less than or equal to 1.5 times the upper limit of normal or with medical waiver
- Estimated creatinine clearance of at least 60 mL/min by Cockcroft-Gault equation
- Female participants of childbearing potential must agree to use acceptable birth control during the study and for 6 months after last dose
- Male participants must agree to use acceptable contraception during the study
- Recovered from prior surgery, radiotherapy, or antineoplastic treatment effects except alopecia
- Willing and able to provide written informed consent
You will not qualify if you...
- Active non-hematologic or lymphoid malignancy other than AML treated with immunotherapy, targeted therapy, or chemotherapy within the last 12 months
- Known active leptomeningeal leukemia requiring intrathecal therapy
- Isolated extramedullary leukemia without meeting bone marrow criteria for acute leukemia unless approved
- Acute promyelocytic leukemia with t(15;17)(q22;q12) PML-RARA
- Chronic myeloid leukemia at any phase
- Anti-cancer therapy within 14 days prior to first treatment day except hydroxyurea or leukapheresis
- Receiving other investigational agents
- Pregnant or breastfeeding females
- Substance abuse or conditions interfering with participation or study evaluation
- HIV infection with CD4+ T-cell counts below 350 cells/mcL or active hepatitis B or C infection
- Hypersensitivity to hypomethylating agents unless deemed irrelevant
- Unresolved toxicity higher than CTCAE Grade 1 from prior therapy except alopecia
- Concurrent conditions compromising ability to tolerate treatment or study conduct including unstable angina, severe heart failure, uncontrolled hypertension, significant cardiac arrhythmia or ECG abnormalities
- Recent major cardiovascular events within past 6 months
- Uncontrolled seizure disorder within past 2 months
- Unable or unwilling to communicate, cooperate, or follow protocol for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 30 days
Participants receive BP1002 drug therapy either alone or in combination with decitabine as part of the dose escalation and expansion phases.
Multiple visits during treatment period
Duration - Up to 180 days after treatment
Participants are monitored for treatment response and safety including laboratory tests, bone marrow aspirates, and blood counts.
Regular visits for assessments
Trial Site Locations
Total: 4 locations
1
Scripps Green Hospital
La Jolla, California, United States, 92037
Actively Recruiting
2
UCLA Medical Center
Los Angeles, California, United States, 90024
Actively Recruiting
3
Weill Cornell Medical College - NewYork-Presbyterian Hospital
New York, New York, United States, 10021
Actively Recruiting
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Michael Hickey
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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