Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide · 1 trial · 2 indications
Identify DLT of BP1002 using non-hematologic and hematologic measures per NCI CTCAE criteria
Identify TEAE of BP1002 using non-hematologic and hematologic measures per NCI CTCAE criteria
Identify and grade treatment-emergent laboratory abnormalities of escalating doses of BP1002 using non-hematologic and hematologic measure per NCI CTCAE criteria
Determine RP2D by evaluating Maximally Tolerated Dose (MTD) data
Evaluate plasma PK of BP1002 using maximum plasma drug concentration (Cmax)
Evaluate in vivo PK of BP1002 using volume of distribution (Vd)
Evaluate in vivo PK of BP1002 using elimination rate constant
Evaluate in vivo PK of BP1002 half-life (t1/2)
Collection of 12-lead ECGs at defined intervals to identify conduction and rhythm changes (treatment emergent QTc elevations or other treatment emergent changes in ECG intervals)
Flow cytometry will be performed using peripheral blood to evaluate Bcl-2 target inhibition by BP1002 on pre and post treatment samples
Evaluate ADA via peripheral blood
| Arm | Type | Description |
|---|---|---|
| Relapsed/Refractory AML - BP1002 monotherapy | EXPERIMENTAL | BP1002 monotherapy dose escalation |
| Relapsed/Refractory AML - BP1002 in combination with decitabine | EXPERIMENTAL | BP1002 single dose in combination with decitabine |
| Name | Type | Description |
|---|---|---|
| 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 |
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 ex...