Early Phase 1 Prostate Cancer Trial, Recruiting NCT07156045 Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences Condition: Prostate Cancer
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Early Phase 1 Prostate Cancer Trial, Recruiting

NCT07156045
Recruiting Early 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:

  • People who have been diagnosed with metastatic castration-resistant prostate cancer (prostate cancer that has spread and is no longer responding to hormone-lowering treatment)
  • People whose testosterone levels in the blood are very low, at a level consistent with castration therapy (below 50 ng/dL or 1.7 nmol/L)
  • People whose cancer cells test positive for a protein called PSMA
  • People whose cancer has continued to grow or spread despite treatment to lower testosterone, shown by at least one of: three rising PSA blood test results taken at least one week apart; two or more new areas of cancer found on a bone scan; or measurable cancer spread visible on a CT or MRI scan
  • People who are expected to live at least 6 months
  • People whose side effects from any previous cancer treatment have largely resolved to a mild level by the time of joining (except for hair loss or hearing loss)
  • People with a physical functioning score of 0–2 on a standard scale used by doctors to measure how well a patient can carry out daily activities (confirm with trial site)
  • People who are willing to take part voluntarily and agree to follow the trial schedule and visits

Who may not be able to join:

  • People who have previously received certain cell-based therapies, such as dendritic cell therapy, CAR-T therapy, NK cell therapy, or similar treatments
  • People who have a known history of allergic reactions to biological medicines (large-molecule drugs such as antibodies or protein-based treatments)
  • People whose blood counts or organ function fall outside acceptable ranges, including low levels of white blood cells, platelets, or red blood cells; poor liver or kidney function; abnormal blood clotting results; or serious lung conditions such as active tuberculosis, chronic obstructive pulmonary disease, or interstitial lung disease
  • People who have previously received any treatment that specifically targets the PSMA protein
  • People who have an active autoimmune disease (such as inflammatory bowel disease, multiple sclerosis, uveitis, or connective tissue disease), or who need long-term immune-suppressing medication, or who the trial doctor believes is likely to have a relapse of autoimmune disease within 3 months
  • People who have had another type of cancer (other than certain common skin cancers) within the past 5 years that is currently active or requires treatment
  • People who currently have an active infection being treated, have needed intravenous antibiotics for 7 or more days in the past 6 weeks, or have needed oral antibiotics in the past week
  • People with untreated chronic hepatitis B, hepatitis B carriers with a high viral load in the blood, or people with active hepatitis C
  • People who have taken part in another clinical trial and received a study drug within the past 3 months
  • People who are unable to use effective contraception during the trial
  • People whom the trial doctor considers unsuitable for any other reason that could affect their participation or safety

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 9 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

GP referral letter

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Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Registry
ClinicalTrials.gov
Start date
1 September 2025
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Occurrence of treatment related adverse events as assessed by CTCAE v5.0

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: 9 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