A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBio-Path Holdings, Inc.
About this trial
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 criteria
Qualifiers
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
Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 or 2
For the dose expansion phase, participants with documented diagnosis of AML who are eligible for decitabine therapy
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN); and
Disqualifiers
Active non-hematologic or lymphoid malignancy other than AML treated with immunotherapy, targeted therapy or chemotherapy within the previous 12 months
Known, active leptomeningeal leukemia requiring intrathecal therapy. NOTE: Participants with a history of CNS disease may be allowed to participate based on at least 1 documented, negative spinal fluid assessment within 28 days prior to Screening
Isolated potentially treatable extramedullary leukemia without also meeting bone marrow criteria for acute leukemia (for AML usually ≥ 5% blasts in BMA or biopsy). Participants may have leukemia with lower blast counts (Döhner 2017). Bio-Path Holdings and Investigator concurrence required.
Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) PML-RARA
Trial design
Treatments tested in this trial
- BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide
- Decitabine (in combination with BP1002)
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov