NCT07457164

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

A Phase 2, Open-Label, Single-Arm, Multicentre Study Investigating the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Teverelix DP, a Gonadotropin-releasing Hormone (GnRH) Antagonist, in Patients With Advanced Prostate Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Antev Ltd. · Industry
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Prostate Cancer
• GnRH Antagonist

Interventions

Type	Name	Description
DRUG	Teverelix DP 180 mg	Teverelix DP 540 mg Day 1 and 360 mg every 6 weeks from week 4 to week 16.

Timeline

• Start date: 2026-07-01
• Primary completion: 2027-09-01
• Completion: 2027-12-01
• First posted: 2026-03-09
• Last updated: 2026-03-12

Regulatory

• FDA-regulated drug study