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

Part of paid clinical trials in La Jolla, California.

Sponsor
Bio-Path Holdings, Inc.
Study ID
NCT05190471
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Acute Myeloid Leukemia Refractory
  • Acute Myeloid Leukemia, in Relapse

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide — DRUG
    Dose escalation of BP1002 monotherapy
  • Decitabine (in combination with BP1002) — DRUG
    Dose expansion of BP1002 in combination with decitabine

Study Details

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).

Key Dates

Start date
Aug 16, 2022
Status verified
Mar 2025
Primary completion
Mar 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Relapsed/Refractory AML - BP1002 monotherapy
    BP1002 monotherapy dose escalation
  • Experimental: Relapsed/Refractory AML - BP1002 in combination with decitabine
    BP1002 single dose in combination with decitabine

Primary Outcome Measure

Identify Dose Limiting Toxicity (DLT) of BP1002 [ Time Frame: 30 days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Scripps Green HospitalLa JollaCalifornia92037
Kiley Borchard
[email protected]
858-554-9253
David Hermel, MD (PRINCIPAL_INVESTIGATOR)
UCLA Medical CenterLos AngelesCalifornia90024
Gary Schiller, MD
Gary Schiller, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medical College - NewYork-Presbyterian HospitalNew YorkNew York10021
Dunay Bach
[email protected]
212-746-4447
Gail Roboz, MD
[email protected]
646-962-2700
Gail J Roboz, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Miranda Lim, BSN, RN
[email protected]
713-794-1722
Maro Ohanian, D.O.
[email protected]
713-792-2631
Maro Ohanian, D.O. (PRINCIPAL_INVESTIGATOR)

Find similar trials in La Jolla, CA

By research site
Scripps Green Hospital· La Jolla, CAUCLA Medical Center· Los Angeles, CAWeill Cornell Medical College - NewYork-Presbyterian Hospital· New York, NYMD Anderson Cancer Center· Houston, TX

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