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OncoMatch/Clinical Trials/NCT05190471

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

Is NCT05190471 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide and Decitabine (in combination with BP1002) for acute myeloid leukemia, in relapse.

Phase 1RecruitingBio-Path Holdings, Inc.NCT05190471Data as of May 2026

Treatment: BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide · Decitabine (in combination with BP1002)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).

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Excluded: PML PML-RARA fusion

Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) PML-RARA

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: any therapy known to be active for refractory/relapsed AML — refractory/relapsed

failed treatment with available therapies known to be active for refractory/relapsed AML

Cannot have received: anti-cancer therapy

Exception: hydroxyurea or leukapheresis

Receipt of any anti-cancer therapy within 14 days prior to C1D1, with the exception of hydroxyurea or leukapheresis

Cannot have received: investigational agent

Participants may not be receiving any other investigational agents

Lab requirements

Kidney function

Estimated creatinine clearance ≥60 mL/min (Cockcroft-Gault equation)

Liver function

AST and ALT ≤2.5x ULN; total bilirubin ≤1.5x ULN (waiver possible with justification)

AST and ALT ≤2.5x ULN; total bilirubin ≤1.5x ULN (waiver possible); estimated creatinine clearance ≥60 mL/min

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Scripps Green Hospital · La Jolla, California
  • UCLA Medical Center · Los Angeles, California
  • Weill Cornell Medical College - NewYork-Presbyterian Hospital · New York, New York
  • MD Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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