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Advanced Prostate CancerPhase 2NCT07457164

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 study testing Teverelix DP 180 mg in people with Advanced Prostate Cancer and GnRH Antagonist, run by Antev Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years, men only
Conditions the study is for
Advanced Prostate Cancer, GnRH Antagonist
What is being tested?
Teverelix DP 180 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Jul 2026to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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
  • Current use of any of the following:
  • o Anti-androgen therapy, including T replacement therapy and 5α-reductase inhibitor treatment etc. within 3 months of enrolment (Spironolactone is a permitted concomitant treatment)
  • Any other medication or herbal product that may affect hormone levels and might, therefore, confound interpretation of the study results (e.g. St. John's wort, red reishi, licorice, white peony, green tea, spearmint, black cohosh, chaste tree, saw palmetto, etc) (within 3 months of enrolment)
  • Has neurological disease, psychiatric disease, drug or alcohol abuse, which could interfere with the patient's proper compliance
  • Has a history of myocardial infarction, unstable symptomatic ischaemic heart disease, any ongoing cardiac arrhythmias of grade >2 (chronic stable atrial fibrillation on stable anticoagulant therapy is allowed), thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other significant cardiac condition (e.g. pericardial effusion, restrictive cardiomyopathy) within the 6 months prior to screening
  • Has congenital long QT syndrome or ECG abnormalities at screening of:
  • Q-wave infarction, unless identified ≥6 months before screening
  • Fridericia corrected QT interval (QTcF interval) >480 msec. If QTcF is prolonged in a patient with a pacemaker, the patient may be enrolled in the study upon discussion with the project clinician
  • If the QTcF interval is 450-480 msec, inclusive, in a patient with current use of medications with known effects on QT interval, the patien may be enrolled in the study following discussion with the Medical Lead
  • Note: Cardiac arrhythmia grading:
  • Bradyarrhythmias (HR <60/min)
  • Tachyarrhythmias (HR >100/min)
  • Supraventricular arrhythmias - arrhythmias that originate in the sinoatrial node, atrial myocardium or atrioventricular node (regular QRS complex)
  • Ventricular arrhythmias - arrhythmias that originate below the atrioventricular node (wide QRS complex)
  • Has known or suspected severe renal impairment
  • Has a medical history of diagnosis of, or treatment for, another malignancy within the 2 years prior to administration of the first dose of IMP, or previous diagnosis of another malignancy with evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
  • Is currently using Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic medications
  • Has uncontrolled hypertension despite appropriate medical therapy (sitting blood pressure [BP] of >180 millimetres of mercury [mmHg] systolic and >95 mmHg diastolic at 2 separate measurements taken no more than 60 minutes apart during the screening visit). Patients with isolated systolic BP measurements >180 mmHg may be rescreened. Patients with isolated systolic BP measurements 141 to 180 mmHg or isolated diastolic BP measurements ≥95 mmHg, although eligible, should be referred for further management of hypertension if indicated
  • Has known, previously diagnosed HIV infection, active chronic hepatitis B or C, life-threatening illness unrelated to prostate cancer, or any serious medical condition that could, in the investigator's opinion, potentially interfere with participation in this study. Specific screening for chronic viral illness is at the discretion of the site and/or local Institutional Review Board (IRB)
  • Has been exposed to another investigational drug within the 3 months prior to screening
  • Has anticipated non-availability for study visits/procedure
  • Plans to undergo surgery during the study period
  • Known presence of hepatic metastases

About this study

Official title: 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

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:

Read more

•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.

Being tested
Teverelix DP 180 mg
Keywords
Teverelix, Pharmacokinetics, Pharmacodynamics, Prostatic Diseases, Urogenital Diseases
Medical subject headings
Prostatic Diseases, Urogenital Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Teverelix DP 180 mgDrug

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

Study groups in NCT07457164
Study groupRoleWhat they receive
Teverelix DP 180 mgExperimentalParticipants 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)
Receives: Drug: Teverelix DP 180 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%

    Measured: 22 weeks

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

    Measured: 22 weeks

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

    Measured: 22 weeks

  4. 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)

    Measured: 22 weeks

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

    Measured: 22 weeks

Secondary outcomes (5)

  1. Evaluate the change in Prostate Specific Antigen (PSA)

    Measured: 22 weeks

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

    Measured: 22 weeks

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

    Measured: 22 weeks

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

    Measured: 22 weeks

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

    Measured: 22 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07457164
Sponsor's protocol ID
ANT-1111-05
Status last verified
Mar 2026
First submitted
24 Feb 2026
Last updated
12 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Teverelix DP 180 mg in people with Advanced Prostate Cancer and GnRH Antagonist, run by Antev Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the efficacy of a dosing regimen of teverelix DP in attaining by Day 29 and sustaining to Day 155 castration rate (time frame: 22 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07457164.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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