A Phase I/Ib Study of BP1002 (a Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)
Bio-Path Holdings, Inc.
Summary
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults ≥18 years of age, with histologic evidence of refractory/relapsed AML who have failed treatment with available therapies known to be active for refractory/relapsed AML 2. Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 or 2 3. For the dose expansion phase, participants with documented diagnosis of AML who are eligible for decitabine therapy 4. Participants must have adequate hepatic and renal functions as defined by: 1. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN); and 2.…
Interventions
- DrugBP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide
Dose escalation of BP1002 monotherapy
- DrugDecitabine (in combination with BP1002)
Dose expansion of BP1002 in combination with decitabine
Locations (4)
- Scripps Green HospitalLa Jolla, California
- UCLA Medical CenterLos Angeles, California
- Weill Cornell Medical College - NewYork-Presbyterian HospitalNew York, New York
- MD Anderson Cancer CenterHouston, Texas