Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Talabostat Mesylate, Talabostat
BXCL701 · 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...
BXCL701 is being studied for the treatment of metastatic pancreatic ductal adenocarcinoma, a form of pancreatic cancer that has spread beyond the pancreas. It is an investigational small molecule being developed in oncology by BioXcel Therapeutics, Inc. and is not an approved therapy.
BXCL701 is being developed by BioXcel Therapeutics, Inc., which trades under the ticker BTAIQ. The company is advancing the small molecule as an oncology candidate, with its clinical work focused on metastatic pancreatic ductal adenocarcinoma.
BXCL701 is in Phase 2 clinical development. Its single registered trial is a Phase 2 study in metastatic pancreatic ductal adenocarcinoma. BXCL701 is investigational and is not FDA approved for any use.
BXCL701 is being evaluated in trial NCT05558982, titled BXCL701 and Pembrolizumab in Patients With Metastatic Pancreatic Ductal Adenocarcinoma. The Phase 2 study is active but not recruiting, is uncontrolled, and is expected to enroll 22 patients aged 18 years and older in the United States.
Yes. The Phase 2 trial NCT05558982 evaluates BXCL701 in combination with pembrolizumab in patients with metastatic pancreatic ductal adenocarcinoma. The study is an open, uncontrolled design with a planned enrollment of 22 participants and is currently active but not recruiting.
No. BXCL701 is an investigational small molecule still in clinical development and has not been approved by the FDA. Its only registered study is a Phase 2 trial in metastatic pancreatic ductal adenocarcinoma that is active but no longer recruiting participants.