BP1002 + Decitabine for Acute Myeloid Leukemia

Recruiting at 3 trial locations

Overseen By Michael Hickey

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bio-Path Holdings, Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Gail J Roboz, MD

Principal Investigator

Weill Cornell Medical College - New York-Presbyterian Hospital

Eligibility Criteria

Adults over 18 with refractory/relapsed AML who've failed other treatments can join. They must have a decent performance status (ECOG 0-2), good liver and kidney function, agree to birth control, and be recovered from past cancer therapies. Excluded are those with certain leukemia types, recent anti-cancer therapy, HIV/AIDS or hepatitis B/C infections, pregnant or breastfeeding women, hypersensitivity to similar drugs, uncontrolled health issues like heart disease.

Inclusion Criteria

Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN)

I am over 18 and my AML has not responded to treatment.

Usually total bilirubin ≤ 1.5 ULN. In specific cases the PI may request a waiver of this requirement with medical justification and agreement with the medical monitor and Bio-Path Holdings. And

Exclusion Criteria

I have not had a heart attack, stroke, or similar event in the last 6 months.

You have a history of drug or alcohol abuse, or any medical, psychological, or social conditions that may affect your ability to take part in the study or to accurately evaluate the study results.

I have chronic myeloid leukemia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of BP1002 to evaluate safety and determine the maximum tolerated dose

30 days

Multiple visits for dose administration and monitoring

Dose Expansion

BP1002 is assessed in combination with decitabine to evaluate safety and efficacy

180 days

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BP1002
• Decitabine

Trial Overview The trial is testing BP1002 alone in escalating doses for safety and tolerability initially. After that phase, it will test BP1002 combined with decitabine to find the effective dose range and observe any potential benefits against AML.

Participant Groups

Group I: Relapsed/Refractory AML - BP1002 monotherapy Experimental Treatment 1 Intervention

BP1002 monotherapy dose escalation

Group II: Relapsed/Refractory AML - BP1002 in combination with decitabine Experimental Treatment 2 Interventions

BP1002 single dose in combination with decitabine

Who Is Running the Clinical Trial?

Bio-Path Holdings, Inc.

Lead Sponsor

Trials

6

Recruited

300+