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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 is a Phase 1 study that has completed, run by BioXcel Therapeutics. The registered enrollment target is 98 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03910660
The ClinicalTrials.gov registry entry for NCT03910660 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioXcel Therapeutics, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which BXCL701 plus Pembrolizumab is the first listed.
NCT03910660 reports 0 study locations.
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.
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