OncRef

Clinical Trial: NCT03910660

A Trial of BXCL701 and Pembrolizumab in Patients With mCRPC Either Small Cell Neuroendocrine Prostate Cancer or Adenocarcinoma Phenotype.

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:BioXcel Therapeutics Inc
Information Provided By:BioXcel Therapeutics Inc
Last Update Posted:2026-05-15

Study Overview

Brief 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.

Official Title

Phase 1b/2 Study of BXCL701, a Small Molecule Inhibitor of Dipeptidyl Peptidases, Administered in Combination With the Anti-Programmed Cell Death 1 Monoclonal Antibody Pembrolizumab in Patients With mCRPC Either Small Cell Neuroendocrine Prostate Cancer or Adenocarcinoma Phenotype

Conditions

Prostate Cancer, Neuroendocrine Tumors, Small Cell Carcinoma

Intervention / Treatment

  • Drug: BXCL701 plus Pembrolizumab
  • Drug: BXCL701 monotherapy

Other Study ID Numbers

  • BXCL701-201

Start Date (Actual)

2019-02-12

Primary Completion Date (Actual)

2023-10-31

Study Completion Date (Actual)

2025-08-31

Enrollment (Actual)

98

Study Type

Interventional

Phase

Phase 1, Phase 2