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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Talabostat is an investigational small molecule being studied for prostate cancer, specifically metastatic castrate-resistant prostate cancer (mCRPC) with either small cell neuroendocrine or adenocarcinoma phenotype. It has been evaluated in combination with pembrolizumab in adult male patients. It is in Phase 1/2 clinical development and is not an approved therapy.
Talabostat is being developed by BioXcel Therapeutics, Inc., which trades under the ticker BTAIQ. The company sponsored the clinical program evaluating talabostat in prostate cancer. Talabostat is also referred to by the code BXCL701.
Talabostat is in Phase 1/2 clinical development. Its single registered trial, NCT03910660, was a Phase 1/Phase 2 study that has been completed. Talabostat is investigational and is not an FDA-approved treatment for prostate cancer or any other indication.
Talabostat has been studied in trial NCT03910660, a completed Phase 1/Phase 2 trial of talabostat (BXCL701) combined with pembrolizumab in participants with metastatic castrate-resistant prostate cancer, either small cell neuroendocrine prostate cancer or adenocarcinoma phenotype. The trial enrolled 97 male participants aged 18 years and older across the United States and United Kingdom.
Yes, BXCL701 is an alternative designation for talabostat. BioXcel Therapeutics uses the code BXCL701 for the same investigational small molecule, and the completed prostate cancer trial NCT03910660 is titled as a trial of talabostat (BXCL701) with pembrolizumab. Readers searching either name are looking at the same drug candidate.
Yes, trial NCT03910660 was a randomized, controlled study, though it was not double-blind. It enrolled 97 participants and has been completed. The trial evaluated talabostat in combination with pembrolizumab in metastatic castrate-resistant prostate cancer and did not use biomarker selection for enrollment.