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NCT03910660 · ClinicalTrials.gov registry record · Phase 1
A Trial of BXCL701 and Pembrolizumab in Patients With mCRPC Either Small Cell Neuroendocrine Prostate Cancer or Adenocarcinoma Phenotype.
A Phase 1 study, sponsored by BioXcel Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
NCT03910660: Completed Phase 1 study, sponsored by BioXcel Therapeutics.
NCT03910660 is a Phase 1 study that has completed, run by BioXcel Therapeutics. The registered enrollment target is 98 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03910660, a Phase 1 study, has completed, sponsored by BioXcel Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
Study Summary
An open-label, multicenter, Phase 1b/2 study to identify the recommended Phase 2 dose and assess the efficacy and safety of BXCL701 administered orally, as monotherapy and in combination with PEMBRO, in patients with mCRPC. Patients enrolled in the Phase 2a portion of the study will have either Small Cell Neuroendocrine Prostate Cancer(SCNC)(Cohort A) or adenocarcinoma phenotype (Cohort B), while the Phase 2b randomized portion of the study will enroll only the histologic subtype(s) showing preliminary evidence in Phase 2a. The study will also assess other efficacy parameters, such as rPFS, PSA PFS, OS, and DOR, as well as the safety of the combined treatment. The study will consist of three components.
Primary Outcome
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.
Interventions
- DRUG BXCL701 plus Pembrolizumab
- DRUG BXCL701 monotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2019-02-12 |
| Est. Completion | 2025-08-31 |
| Phase | Phase 1 |
What the finished NCT03910660 record still lists
NCT03910660 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher).
The record links to 0 conditions, and to 2 interventions - of which BXCL701 plus Pembrolizumab is the first listed.
NCT03910660 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03910660 about?
NCT03910660 is a clinical study titled "A Trial of BXCL701 and Pembrolizumab in Patients With mCRPC Either Small Cell Neuroendocrine Prostate Cancer or Adenocarcinoma Phenotype.". An open-label, multicenter, Phase 1b/2 study to identify the recommended Phase 2 dose and assess the efficacy and safety of BXCL701 administered orally, as monotherapy and in combination with PEMBRO, in patients with mCRPC. Patients enrolled in the Phase 2a portion of the study will have either Smal...
What is the current status of trial NCT03910660?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2019-02-12. Estimated completion is 2025-08-31.
What interventions are being tested in trial NCT03910660?
The interventions under investigation include: BXCL701 plus Pembrolizumab (DRUG), BXCL701 monotherapy (DRUG).
Who is sponsoring clinical trial NCT03910660?
This trial is sponsored by BioXcel Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03910660's enrollment target sits among peer trials
98 592nd of 2000 higher than 1,404 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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