Phase 2 Prostate Cancer Trial, Recruiting NCT06609005 Sponsor: Shenzhen Ionova Life Sciences Co., Ltd. Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT06609005
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have given written agreement to take part in the trial.
  • You are male and aged 18 or older.
  • You have been diagnosed with prostate cancer (a specific type called adenocarcinoma) confirmed by a tissue test.
  • Your prostate cancer has stopped responding to hormone-lowering treatments, and your testosterone levels are very low (below 50 ng/dL).
  • Your cancer has spread to other parts of the body (metastatic).
  • You are currently receiving treatment to lower testosterone (via injections or implants), or you have had both testicles surgically removed.
  • You have previously received at least one course of chemotherapy (taxane-based) and at least one hormonal treatment (such as abiraterone or enzalutamide) — or you were unable to tolerate or refused chemotherapy.
  • You are generally well enough to carry out daily activities with little or no limitation (confirm with trial site).
  • Your bone marrow, liver, and kidneys are working well enough based on blood tests.
  • Your blood clotting level is within an acceptable range (confirm with trial site).
  • You are able to swallow the study medication.
  • Your doctors expect you to live for more than 3 months.

Who may not be able to join:

  • You have a bowel condition such as Crohn's disease, or have had major surgery on your digestive system that could affect how your body absorbs medication.
  • You have a history of problems with your pituitary gland or adrenal glands.
  • You have diabetes that is not well controlled.
  • You have significantly abnormal potassium or sodium levels in your blood.
  • You have a serious non-cancer illness (such as kidney blockage or liver failure) that could interfere with the trial, in the opinion of the medical team.
  • You have an active or unstable heart or stroke-related condition, including blood clots.
  • You have a history of heart failure, significant heart disease, or a heart attack within the last 6 months.
  • You have an abnormal heart rhythm reading on an ECG (a specific measurement called QTcF) (confirm with trial site).
  • You have an active infection or another condition that would make taking steroid medication unsafe.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 1 908 240 7514

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Shenzhen Ionova Life Sciences Co., Ltd.
Registry
ClinicalTrials.gov
Start date
23 January 2025
Est. completion
17 January 2028

Where this trial is recruiting

🇨🇳 China 🇺🇸 United States

Primary endpoints

Phase 1: Maximum tolerated dose (MTD); Phase 1: Recommended dose range (RDR); Phase 2: Evaluate Radiographic progression-free survival (rPFS); Phase 2: Evaluate overall response rate (ORR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov