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 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: ANT-1111-05
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Teverelix; Pharmacokinetics; Pharmacodynamics; Prostatic Diseases; Urogenital Diseases

Outcome Measures

Primary Outcomes (5)

• To evaluate the efficacy of a dosing regimen of teverelix DP in attaining by Day 29 and sustaining to Day 155 castration rate

  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%

  22 weeks

• Evaluate the safety of teverelix DP through the incidence of adverse events.

  22 weeks

• Evaluate the safety of teverelix DP through the incidence of abnormalities in clinical laboratory data

  22 weeks

• Evaluate the safety of teverelix DP by assessing QTc-teverelix DP plasma concentration relationship via 24-hour ECG Holter data collected in a subset of patients (n=30)

  22 weeks

• Evaluate the safety of teverelix DP by assessing the generation of anti-drug antibodies (ADAs) to teverelix (i.e. immunogenicity) in 40 patients

  22 weeks

Secondary Outcomes (5)

• Evaluate the change in Prostate Specific Antigen (PSA)

  22 weeks

• Characterise the effect of teverelix DP on pharmacodynamic parameters total T, LH and FSH in 40 patients

  22 weeks

• Define PK parameters for teverelix DP by maximum observed plasma concentration (Cmax) of teverelix DP

  22 weeks

• Define PK parameters for teverelix DP by area under the concentration-time curve (AUC0-τ) of teverelix DP

  22 weeks

• Define PK parameters for teverelix DP by time to maximum observed plasma concentration (Tmax) of teverelix DP

  22 weeks

Study Arms (1)

Teverelix DP 180 mg

EXPERIMENTAL

Participants receive teverelix DP loading dose on Day 1 (180 mg IM + 2x 180 mg SC) then teverelix DP 2x 180 mg SC on Day 29 and every 6 weeks to Week 16 (Day 113)

Drug: Teverelix DP 180 mg

Interventions

Teverelix DP 180 mg DRUG

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

Teverelix DP 180 mg

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Cisgender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is male, aged ≤85 years (≥18 years) at the beginning of the treatment period (Day 1)
• Has histologically proven advanced adenocarcinoma of the prostate (metastatic or non metastatic, hormone-sensitive, non-curative), suitable for androgen deprivation therapy
• Is treatment naïve for GnRH analogues
• Agrees to practice contraception during the entire study treatment period and for 3 months after the last dose of IMP is administered:
• Either by using double barrier contraception,
• or, is truly sexually abstinent, when this is in line with the preferred and usual lifestyle of the patient
• Note: Periodic abstinence \[e.g. calendar, ovulation, symptothermal, postovulation methods for the female partner with childbearing potential\] and withdrawal are not acceptable methods of contraception.
• Has provided written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed a part of his normal medical care

You may not qualify if:

• Has abnormal screening and/or baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values:
• Liver function test (aspartate aminotransferase \[ASAT/SGOT\], alanine aminotransferase \[ALAT/SGPT\]), exceeding \>2X the ULN range
• Total bilirubin exceeding \>1.5X the ULN range
• Creatinine twice the ULN range
• Uncontrolled diabetes (HbA1c \>7.5%) or previously undiagnosed diabetes mellitus with HbA1c \>6.5%
• An estimated glomerular filtration rate (eGFR) \< 30 mL/min, based on creatinine clearance calculation by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation normalized to an average surface area of 1.73m2, at the screening visit.
• Has any contraindication to the use of teverelix DP
• Has a life expectancy of less than 1 year
• Has T levels \<1.5 ng/mL at screening
• Has a medical history of bilateral orchidectomy
• Any other IMP (within 3 months of enrolment)
• GnRH analogues (subjects must be treatment naïve to GnRH analogues)
• Using any of the following prohibited treatments:
• Within 25 weeks prior to screening: dutasteride
• Within 12 weeks prior to screening: finasteride and others

Sponsors & Collaborators

• Antev Ltd.: lead

MeSH Terms

Conditions

Prostatic Diseases; Urogenital Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 9, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03