Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BP1002
L-Bcl-2 antisense oligonucleotide · 1 trial · 10 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 BP1002 using non-hematologic and hematologic measures per NCI CTCAE criteria
Collection of 12-lead EKGs at defined intervals to identify conduction and rhythm changes (treatment emergent QTc elevations or other treatment emergent changes in EKG intervals)
Determine RP2D by evaluating Maximally Tolerated Dose (MTD) data: Any Dose Limiting Toxicity (DLT) observed will trigger an expansion of a cohort from 3 to 6 patients. A second DLT at any dose level will identify the Maximum Dose. The dose below that will be the MTD.
Evaluate in vivo PK of BP1002 using maximum plasma drug concentration (Cmax)
Evaluate in vivo PK of BP1002 volume of distribution (Vd)
Evaluate in vivo PK of BP1002 elimination rate constant
Evaluate in vivo PK of BP1002 half-life (t1/2)
12-lead EKG assessments will be collected and analyzed for conduction and rhythm changes (treatment emergent QTc elevations or other treatment emergent changes in EKG intervals) from those the EKG obtained immediately before the first BP1002 dose, and after BP1002 dose, and will mirror the time points used to collect the plasma PK assessments
| Arm | Type | Description |
|---|---|---|
| BP1002 monotherapy | EXPERIMENTAL | L-Bcl-2 Antisense oligonucleotide (BP1002) is given in a sequential, dose escalation design. Starting dose is 20mg/m\^2. |
| Name | Type | Description |
|---|---|---|
| L-Bcl-2 antisense oligonucleotide | DRUG | There will be 2 planned dose levels, 20, and 40 mg/m\^2. Successive cohorts of eligible patients with will be treated with BP1002. BP1002 is given as an intravenous infusion, twice weekly, as 8 doses per 28-day cycle. Cycles may be repeated every 4 weeks. |
Inclusion Criteria: 1. Adults ≥18 years of age 2. Patient has a life expectancy ≥ 3 month 3. Patient has relapsed or refractory disease Relapsed lymphoma: Relapsed lymphoma is disease that has responded to treatment but then returns. Refractory lymphoma: Failure to achieve complete response at ...