Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Neuroendocrine Tumors
  • Prostate Cancer
  • Small Cell Carcinoma
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

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 mCRPC with either SCNC or adenocarcinoma phenotype. The study will also assess other efficacy parameters, such as rPFS, PSA P...

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 mCRPC with either SCNC or adenocarcinoma phenotype. 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 2 stages: 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 of every 21 days will be assessed and confirmed in patients with metastatic castration-resistant prostate cancer (mCRPC). In Cohort 1, the initial dose level of BXCL701 will be 0.4 mg; if there are no safety concerns, this will be escalated to a total daily dose of 0.6 mg. Efficacy Stage (Simon 2-Stage) - in which patients will be treated with BXCL701 combined with PEMBRO. Patients will be assigned to 1 of 2 cohorts based on phenotype. Cohort A: Patients with any Small Cell/Neuroendocrine features, either de novo or treatment-emergent included mixed SCNC. Cohort B: Cohort B: Patients with adenocarcinoma and no evidence of small cell or neuroendocrine features. Lead-in Stage: Patients will be observed for dose-limiting toxicity (DLT) during Cycle 1. Three patients will be treated initially with 0.4 mg BXCL701 plus PEMBRO: If there are no DLTs in Cycle 1, the dose of BXCL701 will be escalated to a total daily dose of 0.6 mg in the next cohort of 3 patients. If ?1 of the 3 original patients has a DLT in Cycle 1, after a discussion between the sponsor and the investigator, either 3 patients (if 1 patient experiences a DLT) or 6 to 9 patients (if 2 or 3 patients experiences a DLT) will be added at the 0.4 mg BXCL701 dose level. For this expanded 0.4 mg cohort: If less than one-third of the patients experience a DLT, consideration will be given to dose escalation to 0.6 mg BXCL701 plus PEMBRO If one-third of the patients experience a DLT, the Efficacy Stage can commence If more than one-third of the patients experience a DLT, a discussion will be held between the investigators and sponsors as to how to proceed. Efficacy Stage: After assessment of the safety and confirmation of the BXCL701/PEMBRO dose schedule (i.e., either 0.6 mg, 0.4mg, or an intermediate total daily dose of BXCL701) to be used in the subsequent stage, the Efficacy Stage 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.

Tracking Information

NCT #
NCT03910660
Collaborators
Not Provided
Investigators
Not Provided