Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BXCL701
Talabostat · 2 trials · 4 indications
CRR was defined as the percentage of participants who achieved 1 or more of the following: objective response by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) criteria; ≥50% decline from baseline in serum Prostate-Specific Antigen (PSA); or Circulating Tumor Cell (CTC) conversion from ≥5/7.5 milliliters (mL) to \<5/7.5 mL per Veridex assay. Objective response rate was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) among participants with evaluable lesions by RECIST v1.1. CR=disappearance of all target and non-target lesions and no new lesions. PR = ≥30% decrease in the sum of diameters (SOD) of target lesions compared to baseline and no new non-target lesion.
The ORR was defined as the percentage of participants with a confirmed CR or PR among participants with evaluable lesions by RECIST v1.1. CR=disappearance of all target and non-target lesions and no new lesions. PR = ≥30% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion.
| Arm | Type | Description |
|---|---|---|
| BXCL701 plus Pembrolizumab | EXPERIMENTAL | - |
| Phase 1B: Talabostat 0.4 mg QD + Pembrolizumab 200 mg | EXPERIMENTAL | Participants will receive the combination of talabostat 0.4 mg QD orally on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle. There will be a 7-day rest period following the last dose of talabostat and Day 1 of the subsequent cycle. |
| Phase 1B: Talabostat 0.6 mg QD + Pembrolizumab 200 mg | EXPERIMENTAL | Participants will receive the combination of talabostat 0.6 mg QD orally on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle. There will be a 7-day rest period following the last dose of talabostat and Day 1 of the subsequent cycle. |
| Phase 1B: Talabostat 0.6 mg TDD + Pembrolizumab 200 mg | EXPERIMENTAL | Participants will receive the combination of talabostat 0.3 mg twice daily (BID) (at a total daily dose \[TDD\] of 0.6 mg) orally on Days 1 to 14 of a 21-day cycle plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle. There will be a 7-day rest period following the last dose of talabostat and Day 1 of the subsequent cycle. |
| Phase 2A (SCNC): Talabostat + Pembrolizumab 200 mg | EXPERIMENTAL | Participants with SCNC will receive the combination of talabostat 0.6 mg QD orally on Days 1 to 14 a 21-day cycle plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle. There will be a 7-day rest period following the last dose of talabostat and Day 1 of the subsequent cycle. |
| Phase 2A (Adenocarcinoma): Talabostat + Pembrolizumab 200 mg | EXPERIMENTAL | Participants with adenocarcinoma will receive the combination of talabostat 0.6 mg QD orally on Days 1 to 14 a 21-day cycle plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle. There will be a 7-day rest period following the last dose of talabostat and Day 1 of the subsequent cycle. |
| Phase 2B (Adenocarcinoma): Talabostat + Pembrolizumab 200 mg | EXPERIMENTAL | Participants with adenocarcinoma will receive the combination of talabostat 0.6 mg QD orally on Days 1 to 14 a 21-day cycle plus pembrolizumab 200 mg IV on Day 1 of each 21-day cycle. There will be a 7-day rest period following the last dose of talabostat and Day 1 of the subsequent cycle. |
| Phase 2B (Adenocarcinoma): Talabostat Monotherapy | EXPERIMENTAL | Participants with adenocarcinoma will receive talabostat 0.6 mg QD orally on Days 1 to 14 a 21-day cycle. There will be a 7-day rest period following the last dose of talabostat and Day 1 of the subsequent cycle. |
| Name | Type | Description |
|---|---|---|
| BXCL701 | DRUG | BXCL701 0.3 mg, orally, twice a day on days 1-14 every 21 days |
| Pembrolizumab | DRUG | Pembrolizumab 200 mg intravenous (IV) on day 1 every 21 days. |
| Talabostat | DRUG | Oral Tablets |
Inclusion Criteria: * Histologically-confirmed pancreatic ductal adenocarcinoma with metastatic disease (mixed histology is acceptable as long adenocarcinoma is the dominant histological subtype) * Patient must consent to two mandatory biopsies and have tumor amenable to serial core biopsies * Meas...
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