Phase 2 Prostate Cancer Trial, Recruiting NCT06702995 Sponsor: Evopoint Biosciences Inc. Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT06702995
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:

  • People who are able to understand and sign the official consent form for the study
  • People aged 18 or older at the time of signing the consent form
  • People with a life expectancy of at least 3 months
  • People with a good general level of physical functioning, as measured by a standard oncology scale (ECOG score of 0 or 1)
  • People who have been diagnosed with prostate adenocarcinoma (a specific type of prostate cancer) confirmed by a tissue or cell sample — not the neuroendocrine or small cell types
  • People whose prostate cancer has spread to other parts of the body, confirmed by CT scan, MRI, or bone scan
  • People who are currently receiving hormone-blocking therapy (medical or surgical) to lower testosterone, or who have had both testicles surgically removed; those on medical therapy must continue it throughout the study
  • People whose testosterone level is at or below castration level (50ng/dL or 1.7nmol/L) at the time of screening
  • People whose cancer is continuing to grow or spread despite hormone-blocking treatment, shown by rising PSA levels, measurable disease progression on scans, or two or more new spots found on a bone scan
  • People whose previous treatment history meets specific conditions depending on which part of the trial they are entering — including having had abiraterone acetate treatment that stopped working, and not having used certain newer hormone therapies (confirm with trial site for details on which group applies)
  • People whose blood counts and organ function results are within acceptable ranges during screening
  • People who agree to use effective contraception from the start of the study until at least 3 months after the last dose, and who agree not to donate sperm during this time
  • People who are able to follow all the procedures required by the trial

Who may not be able to join:

  • People who have previously taken certain newer androgen receptor-blocking medicines (such as enzalutamide, apalutamide, proxalutamide, or rezvilutamide), depending on which group of the trial is being considered (confirm with trial site for details)
  • People who have previously received chemotherapy for castration-resistant prostate cancer (including antibody-drug conjugates)
  • People who have previously been treated with an EZH2 inhibitor (such as tazemetostat or similar drugs)
  • People who received most types of anti-cancer treatment within 4 weeks (or within 5 half-lives of the drug, whichever is shorter) before starting the trial, or palliative radiotherapy within 2 weeks before starting
  • People who are planning to receive any other anti-cancer treatment during the trial
  • People who took part in another clinical trial of an anti-cancer treatment within 28 days before starting, or whose last dose of a trial drug was within 28 days of starting this study
  • People who have cancer that has spread to the brain or central nervous system
  • People who have serious bone complications from cancer spread to the bones — such as poorly controlled severe bone pain, fractures in important locations, or spinal cord compression — that occurred in the past 6 months or are expected soon
  • People who have had another type of cancer within the past 3 years that has not been considered clinically cured (some exceptions apply, such as certain treated skin cancers, superficial bladder cancer, breast ductal carcinoma in situ, and papillary thyroid cancer)
  • People who have had a stroke or other serious brain blood vessel event within the past 12 months
  • People who have reduced heart function or a serious heart condition
  • People who have a severe active infection anywhere in the body
  • People with a history of tuberculosis within the past year, or who had tuberculosis more than a year ago but did not receive adequate treatment for it
  • People who are known to be allergic to the study drug or any of its ingredients
  • People who have taken certain medicines that strongly affect how the body processes the study drug (moderate or strong CYP3A inducers or inhibitors) within 14 days before starting (confirm with trial site for the specific medicines involved)
  • People with active autoimmune or inflammatory conditions such as lupus, rheumatoid arthritis, inflammatory bowel disease, or certain other conditions requiring ongoing systemic treatment (some managed conditions, such as controlled thyroid disease or skin conditions not needing systemic therapy, may be exceptions — confirm with trial site)
  • People who have a history of interstitial lung disease, drug-related lung damage, or radiation-related lung inflammation that required steroid treatment, or who have any currently active lung inflammation of this type
  • People with known significant gut or digestive problems that could affect how the body absorbs oral medicines, or who had an abdominal fistula, bowel perforation, or abdominal abscess within the past 6 months
  • People who are HIV positive or have a positive syphilis test
  • People with active hepatitis B or active hepatitis C infection, as determined by specific blood test results
  • People who still have side effects from previous cancer treatment that have not resolved to a mild level (grade 1 or lower), unless the treating doctor considers the ongoing side effect acceptable for safety monitoring (such as hair loss)
  • People with symptomatic fluid build-up around the lungs or heart that has not been controlled after multiple treatments
  • People who have received an organ or tissue transplant from another person
  • People who had major surgery within 4 weeks before starting the trial, or who have a major surgery planned during the study (minor procedures such as biopsies are generally permitted — confirm with trial site)
  • People who received a live or live-attenuated vaccine within 28 days before starting the study (inactivated vaccines are permitted)
  • People whose baseline bone scan shows a pattern called a "superscan" (an abnormal scan result — confirm with trial site)
  • People whom the trial investigators consider unsuitable for the study for any other reason

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 15 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

Principal Investigator: D Ye, M.D., Dingwei Ye

Phone: 86+15010250838

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
Evopoint Biosciences Inc.
Registry
ClinicalTrials.gov
Start date
19 April 2023
Est. completion
13 May 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Ph Ib/IIa: Overall safety profile including adverse events; Ph Ib/IIa: Recommended phase 2 doses (RP2D) of XNW5004 in combination with enzalutamide; Preliminary efficacy determination as evaluated by disease specific response criteria

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: 15 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