A Study Investigating the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Teverelix DP, a Gonadotropin-releasing Hormone (GnRH) Antagonist, in Patients With Advanced Prostate Cancer

The purpose of this clinical trial is to test the effectiveness of a dosing regimen of Teverelix DP castration rate defined as the cumulative probability of testosterone suppression to \< 0.5 ng/mL with the lower bound of the 95% confidence interval (CI) being \> 90% to meet the evaluation criteria for efficacy. The main question it aims to answer is: •Is the dosing regimen of Teverelix DP in this study effective at achieving the required testosterone suppression to castrate levels. Participants will * Receive a single loading dose consisting of 3 injections of teverelix DP (180 mg IM + 2x 180 mg SC) on Day 1. * Receive a maintenance dose consisting of 2 injections (2X 180 mg SC) from week 4 (Day 29) and every 6 weeks up to Week 16 (Day 113). * The first 30 enrolled participants will have 24-hour continuous Holter monitoring performed and 24-hour PK samples will be drawn. The results of this study are intended to support dose selection and provide supportive safety and PK/PD data to enable advancement into a subsequent Phase 3 clinical study in patients with advanced prostate cancer who are at high cardiovascular risk.

NCT Number	NCT07457164
Lead Sponsor	Antev Ltd.
Conditions	Advanced Prostate Cancer, GnRH Antagonist
Enrollment	40 participants
Start Date	2026-07
Primary Completion	2027-09 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-03-12