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.

Must not be taking: Immunotherapy, Chemotherapy, others

Disqualifiers: Non-hematologic malignancy, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment option for individuals with acute myeloid leukemia (AML), a type of blood cancer unresponsive to other treatments. The trial aims to determine the safety and tolerability of a new drug, BP1002, both alone and in combination with decitabine, a chemotherapy drug. Individuals with AML that has recurred or not improved with other treatments might be suitable candidates, particularly if they qualify for decitabine therapy. The trial seeks to assess whether these drugs can manage the cancer more effectively. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot receive any other investigational agents or anti-cancer therapy within 14 days before starting the trial, except for hydroxyurea or leukapheresis.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BP1002 is still undergoing tests for safety and tolerability in individuals with relapsed or hard-to-treat acute myeloid leukemia (AML). Some studies aim to determine the optimal dosage that minimizes side effects.

When combined with decitabine, the primary goal remains to identify the safest dose. Decitabine has approval for other uses, which provides some confidence in its safety. However, since its combination with BP1002 is new, assessing the tolerability of both drugs together is crucial.

In summary, while BP1002 alone and with decitabine is under investigation, researchers continue to evaluate its safety in humans. This process ensures that any side effects remain manageable for those receiving the treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

BP1002 is unique because it works by targeting a specific protein called Bcl-2, which plays a crucial role in cancer cell survival. Most treatments for Acute Myeloid Leukemia (AML) involve chemotherapy drugs like cytarabine and daunorubicin, which attack rapidly dividing cells indiscriminately. BP1002 offers a more targeted approach, potentially leading to fewer side effects and improved outcomes. Additionally, when combined with decitabine, BP1002 might enhance the effectiveness of treatment by making cancer cells more susceptible to attack. Researchers are excited because this combination could offer new hope for patients with relapsed or refractory AML who have limited options.

What evidence suggests that this trial's treatments could be effective for acute myeloid leukemia?

Research has shown that BP1002 targets a protein called Bcl-2, which aids cancer cell survival. By blocking this protein, BP1002 may help kill cancer cells, offering potential benefits for blood cancers like acute myeloid leukemia (AML). Early results suggest that BP1002 can reduce leukemia cell numbers in the body. In this trial, some participants will receive BP1002 alone, while others will receive it in combination with decitabine. Decitabine, already known to help treat AML, has improved outcomes for AML patients, making this combination a promising option. ^{1 2 4 6 7}

Who Is on the Research Team?

Gail J Roboz, MD

Principal Investigator

Weill Cornell Medical College - New York-Presbyterian Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05190471

NCT05190471 | A Clinical Trial of BP1002 in Patients With ... 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 ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-02254

A Clinical Trial of BP1002 in Patients With Refractory ... 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 ...

3. firstwordpharma.com firstwordpharma.com/story/5934794

Bio-Path Holdings Provides Update from Phase 1/1b ... The Company's second product, BP1002, which targets the Bcl-2 protein, is being evaluated for the treatment of blood cancers and solid tumors, ...

4. ancora.ai ancora.ai/en/details/NCT05190471

A Clinical Trial of BP1002 in Patients With Refractory ... This study evaluates the safety and tolerability of escalating doses of BP1002 (Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in patients with refractory.

5. jcto.weill.cornell.edu jcto.weill.cornell.edu/open_clinical_trials/a-phase-iib-study-of-bp1002-a-liposomal-bcl-2-antisense-oligodeoxynucleotide-in-patients-with-refractoryrelapsed-acute-myeloid-leukemia-aml

A Phase I/Ib Study of BP1002 (a Liposomal Bcl-2 Antisense ... This clinical trial is for men and women with acute myeloid leukemia (AML) whose cancer has been treated before and has either recurred or did not respond ...

6. aml-hub.com aml-hub.com/medical-information/liposomal-drug-delivery-in-acute-myeloid-leukemia

Liposomal drug delivery in acute myeloid leukemia - AML Hub CPX-351 has demonstrated its efficacy and safety in clinical trials (Table 1). In 2017, the US Food and Drug Administration approved CPX-351 ...

7. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/acute-myeloid-leukemia

UCLA Acute Myeloid Leukemia Clinical Trials — Los Angeles This study evaluates the safety and tolerability of escalating doses of BP1002 (Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in patients with ...