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Also known as BXCL701
BXCL701 plus Pembrolizumab · 1 trial · 3 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 |
|---|---|---|
| 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 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: All patients must satisfy the following inclusion and exclusion criteria to be eligible for entry into the trial. 1. Patient has evidence of progressive, metastatic castration-resistant disease, as defined by PCWG3 criteria. a. Patients with de novo small cell prostate canc...
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BXCL701 is an investigational small molecule being studied for the treatment of metastatic pancreatic ductal adenocarcinoma and prostate cancer. It is currently in Phase 2 clinical development for these oncology indications.
BXCL701 is being developed by BioXcel Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BTAI.
BXCL701 is in Phase 2 clinical development. It has received Fast Track and Orphan Drug designations from the FDA for its oncology indications.
BXCL701 is being studied in two clinical trials. NCT03910660 is a completed Phase 1 trial combining BXCL701 with pembrolizumab in patients with prostate cancer. NCT05558982 is an active Phase 2 trial of BXCL701 and pembrolizumab in patients with metastatic pancreatic ductal adenocarcinoma.
BXCL701 has been studied in a Phase 1 trial (NCT03910660) for prostate cancer, including small cell neuroendocrine prostate cancer and adenocarcinoma phenotypes. This trial combined BXCL701 with pembrolizumab and has been completed.