PHASE 1B/2 TRIAL OF BXCL701 WITH PEMBRO IN PATIENTS WITH SCNC; NEPC
Research type
Research Study
Full title
A Phase 1b/2 Study of BXCL701, a Small Molecule Inhibitor of Dipeptidyl Peptidases (DPP), Administered in Combination with the Anti-Programmed Cell Death 1 (PD 1) Monoclonal Antibody Pembrolizumab (PEMBRO; Keytruda®) in Patients with Small Cell Neuroendocrine Prostate Cancer (SCNC; NEPC)
IRAS ID
254671
Contact name
Johann de Bono
Contact email
Sponsor organisation
BioXcel Therapeutics, Inc
Eudract number
2018-003734-32
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Prostate cancer is the most common malignancy in men and the second leading cause of cancer-related deaths. This is an open-label, multicenter, Phase 1b/2 study to determine the composite response rate of BXCL701 administered orally and daily, combined with PEMBRO, in patients with prostate cancer. The main purpose of this study is to evaluate the cancer response rates of the investigational drug BXCL701 in combination with the drug Pembrolizumab (PEMBRO; Keytruda®) in subjects with SCNC. An investigational drug is one that has not been approved by the U.S. Food & Drug Administration (FDA), or other regulatory authorities around the world, for use alone or in combination with any drug, for the condition or illness it is being used to treat. BXCL701 is investigational and has not been FDA approved. Pembrolizumab is FDA approved for the treatment of other cancers, but not for prostate cancer; therefore, in this study, Pembrolizumab is also investigational.
The study will consist of 2 stages:
1) Lead-in Stage - in which the safety and tolerability of the combination of BXCL701 administered once daily (QD) on Days 1 to 14 of a 21-day cycle plus PEMBRO 200 mg administered intravenously (IV) on Day 1 every 21 days will be assessed and confirmed in patients with SCNC.
2) Efficacy Stage (Simon 2-Stage) - in which patients with SCNC will be treated with BXCL701 combined with PEMBRO.REC name
London - Brent Research Ethics Committee
REC reference
19/LO/0625
Date of REC Opinion
2 Jul 2019
REC opinion
Further Information Favourable Opinion