MedTrace Logo

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

NCT07457164 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-12

No results posted yet for this study

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

Interventions

DRUG

Teverelix DP 180 mg

Teverelix DP 540 mg Day 1 and 360 mg every 6 weeks from week 4 to week 16.

Sponsors & Collaborators

  • Antev Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-09-30
Completion
2027-12-31
FDA Drug
Yes

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07457164 on ClinicalTrials.gov