A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)
← catalyst calendarNCT05190471 · readout ≤ 224 d
Sponsored by Bio-Path Holdings, Inc. (industry) · BPTH — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
48estimated
Sites
4
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-08-16 | actual | When the study began enrolling |
| Primary completion | Mar 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2022-01-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-03-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Acute Myeloid Leukemia, in Relapse
- Acute Myeloid Leukemia Refractory
Interventions
- Drug: BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide — also filed as Liposomal Bcl-2; L-Bcl-2
- Drug: Decitabine (in combination with BP1002) — also filed as Decitabine
Primary outcomes
what the primary-completion date above is the date OFIdentify Dose Limiting Toxicity (DLT) of BP1002
measured 30 days
Identify and grade treatment-emergent adverse events (TEAE) of escalating doses of BP1002
measured 30 days
Identify and grade treatment-emergent laboratory abnormalities of escalating doses of BP1002
measured 30 days
Recommended Phase 2 (RP2D) of BP1002
measured 210 days
Determine plasma pharmacokinetics (PK) of BP1002 using maximum plasma drug concentration
measured 30 days
Determine plasma pharmacokinetics (PK) of BP1002 using volume of distribution
measured 30 days
Determine plasma pharmacokinetics (PK) of BP1002 using elimination rate constant
measured 30 days
Determine half-life plasma pharmacokinetics (PK) of BP1002
measured 30 days
Identify conduction and rhythm changes (treatment emergent QTc elevations or other treatment emergent changes in ECG intervals) of escalating doses of BP1002
measured 30 days
Determine pharmacodynamics (PD) of BP1002
measured 30 days
Determine anti-drug antibody (ADA) levels of BP1002
measured 30 days
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