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Also known as BXCL701 monotherapy, Talabostat Mesylate
BXCL701 · 2 trials · 4 indications
Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria; circulating tumor cell (CTC) conversion from \>5/7.5 mL to \<5/7.5 mL per Veridex assay; and 50% or greater prostate-specific antigen (PSA) decline from baseline.
To evaluate the response rates, defined by RECIST 1.1 criteria, by histologic subtype in patients treated with the combination of BXCL701 + PEMBRO and with BXCL701 monotherapy.
| Arm | Type | Description |
|---|---|---|
| BXCL701 plus Pembrolizumab | EXPERIMENTAL | - |
| Phase 1b | OTHER | Patients will be observed for dose-limiting toxicity (DLT) during Cycle 1. 3 patients will be treated initially with 0.4 mg BXCL701 plus PEMBRO: If there are no DLTs, the dose of BXCL701 will be escalated to 0.6 mg in the next cohort. If ≥1/3 of patients has a DLT in Cycle 1, either 3 patients (if 1 experience a DLT) or 6 to 9 patients (if 2 or 3 experiences a DLT) will be added at the 0.4 mg dose. At the 0.4mg dose: If \<1/3 of the patients experience a DLT, consideration will be given to dose to 0.6 mg BXCL701 plus PEMBRO. If 1/3 of the patients experience a DLT, the Phase 2a can commence. If \>1/3 of the patients experience a DLT, a discussion will be held as to how to proceed. Following 0.6 mg dose. If there are no DLTs, the Phase 2a can commence. If ≥1/3 patients have a DLT in Cycle 1, after a discussion, 6 to 9 patients will be added at the 0.6 mg dose. For this cohort of 6 to 9 patients: If \</=1/3 of the patients experience a DLT, the Phase 2a can commence |
| Phase 2a | OTHER | After assessment of the safety and confirmation of the BXCL701/+PEMBRO dose schedule to be used in the subsequent stage, the Phase 2a will begin. Eligible patients will receive BXCL701 QD on Days 1 to 14 of a 21-day cycle plus PEMBRO 200 mg administered IV on Day 1 every 21 days. |
| Phase 2b combination | OTHER | Upon completion of the Phase 2a and achievement of the protocol required composite responses for a given histologic subtype, the Phase 2b enrollment will begin for that subtype. Eligible patients will be randomized to receive: • Combination therapy of BXCL701 on Days 1 to 14 of a 21-day cycle plus PEMBRO 200 mg administered IV on Day 1 of every 21 days. |
| Phase 2b monotherapy | OTHER | Upon completion of the Phase 2a and achievement of the protocol required composite responses for a given histologic subtype, the Phase 2b enrollment will begin for that subtype. Eligible patients will be randomized to receive: * Monotherapy BXCL701 on Days 1 to 14 of a 21-day cycle. Upon radiographic disease progression with monotherapy, crossover to combination treatment is allowed. |
| 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. |
| BXCL701 plus Pembrolizumab | DRUG | BXCL701 tablets dosage strengths include 0.05mg and 1mg tablets for oral administration. BXCL701 will be administered orally as 0.05mg and 1mg tablets. Patients will take the prescribed number of tablets on Days 1 to 14 of each cycle, for a total daily dose of 0.4 mg, 0.6 mg, or an intermediate dose. BXCL701 will be continued until PD or unacceptable toxicity, or closure of the study by the sponsor; no maximum duration of therapy has been set. BXCL701 should not be taken on an empty stomach. On days when PD studies are being performed, BXCL701 should be administered at the study center and should be administered at approx. the same time of day on each treatment day in the cycle. In cycles in which PD are not evaluated, BXCL701 also should be administered at approx. the same time of day on each treatment day. The PEMBRO dose will be 200 mg, administered as an IV infusion over 30 mins. on Day 1 of each 21-day cycle. |
| BXCL701 monotherapy | DRUG | BXCL701 tablets dosage strengths include 0.05mg and 1mg tablets for oral administration. BXCL701 will be administered orally as 0.05mg and 1mg tablets. Patients will take the prescribed number of tablets on Days 1 to 14 of each cycle, for a total daily dose of 0.4 mg, 0.6 mg, or an intermediate dose. BXCL701 will be continued until PD or unacceptable toxicity, or closure of the study by the sponsor; no maximum duration of therapy has been set. BXCL701 should not be taken on an empty stomach. On days when PD studies are being performed, BXCL701 should be administered at the study center and should be administered at approx. the same time of day on each treatment day in the cycle. In cycles in which PD are not evaluated, BXCL701 also should be administered at approx. the same time of day on each treatment day. |
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 an investigational small molecule being studied in oncology for metastatic pancreatic ductal adenocarcinoma and prostate cancer, including small cell neuroendocrine prostate cancer. It is being developed by BioXcel Therapeutics, Inc. (BTAI) and is not yet approved for any indication.
BXCL701 is a small molecule therapeutic. Its specific molecular target is not stated in the available information. It is being evaluated in combination with pembrolizumab in clinical trials for metastatic pancreatic ductal adenocarcinoma and prostate cancer.
BXCL701 is being developed by BioXcel Therapeutics, Inc., which trades on the Nasdaq under the ticker BTAI. The company is evaluating the drug in Phase 2 clinical development for metastatic pancreatic ductal adenocarcinoma and in prostate cancer.
BXCL701 is in Phase 2 clinical development. It has received Fast Track and Orphan Drug designations from the FDA. The drug remains investigational and has not been approved for commercial use.
BXCL701 is being studied in two registered trials. NCT05558982 is a Phase 2 trial of BXCL701 plus pembrolizumab in metastatic pancreatic ductal adenocarcinoma, currently active but not recruiting. NCT03910660 was a completed Phase 1 trial in prostate cancer, including small cell neuroendocrine prostate cancer.