Phase 1 Prostate Cancer Trial, Recruiting NCT07189403 Sponsor: Daiichi Sankyo Condition: Prostate Cancer
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Phase 1 Prostate Cancer Trial, Recruiting

NCT07189403
Recruiting Phase 1

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 are 18 years of age or older
  • You have been diagnosed with a specific type of cancer (either adrenocortical carcinoma or prostate adenocarcinoma), confirmed by a tissue sample test
  • You are reasonably active and able to care for yourself day-to-day, with only minor limitations due to your illness (or if your activity is limited mainly because of cancer-related pain)
  • Your liver, kidneys, and bone marrow are functioning well enough, based on recent blood tests taken within the last two weeks
  • You are willing and able to sign a consent form before any trial procedures begin

For people with advanced prostate cancer that has stopped responding to hormone treatment (mCRPC), these additional criteria also apply:

  • You have already received at least one hormone-blocking drug treatment (such as abiraterone, enzalutamide, darolutamide, or apalutamide) for at least 12 weeks
  • You have already had at least one chemotherapy treatment, were considered medically unsuitable for chemotherapy, or chose not to have chemotherapy
  • Your cancer has been shown to be getting worse, based on rising PSA levels, growth of tumours in soft tissue, or spread in the bones

Who may not be able to join:

  • You have a history of problems with your pituitary gland
  • You currently have an autoimmune disease that is active or not well controlled and requires ongoing medication
  • You need to take steroid medicines (other than for your cancer) at doses higher than a low daily threshold (confirm with trial site for exact dose details)
  • You have an active infection or another condition that would make taking steroids unsafe
  • You have cancer that has spread to your spinal cord or brain and is untreated, causing symptoms, or currently being treated with steroids, anti-seizure drugs, or radiotherapy
  • You have serious heart or blood vessel disease that is not well controlled
  • You have had a different type of cancer in the past, unless it was fully treated at least 3 years ago with no signs of it returning, or it was a low-risk skin cancer or early-stage cancer fully treated with no remaining signs of disease
  • You still have significant side effects from previous cancer treatments that have not yet cleared up
  • You are unable to swallow the trial tablets whole or follow the required dosing schedule
  • You have a stomach or bowel condition, or take certain stomach acid medicines (such as antacids or proton pump inhibitors), that might affect how the trial drug is absorbed into your body

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 13 July 2026
Phase 1: approximately ~10% 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: 908-992-6400

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 1
Sponsor
Daiichi Sankyo
Registry
ClinicalTrials.gov
Start date
4 November 2025
Est. completion
1 March 2028

Where this trial is recruiting

🇫🇷 France 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Number of Participants Reporting Dose-limiting Toxicities (DLTs), Treatment-emergent Adverse Events (TEAEs), TEAEs Associated With Treatment Discontinuation, Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI) - All Patients

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: 13 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