Study of XNW5004 Tablets in Advanced Prostate Cancer (NCT07730580) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study of XNW5004 Tablets in Advanced Prostate Cancer
242 participantsStarted 2026-07-13
Plain-language summary
Phase Ib A preliminary design of 2 cohorts is planned for this phase, with 3-6 participants to be enrolled in each cohort. A total of 6-12 participants with advanced prostate cancer are planned to be enrolled in this phase. The study will be conducted at multiple investigational sites.
Phase II A preliminary design of 5 cohorts is planned for this phase. Cohorts 1, 2, and 3 are preset with 2 dose groups each, and each dose group plans to enroll 20-30 participants. Cohort 4 plans to enroll 20-50 participants. Cohort 5 will be adjusted based on results from prior study phases. A total of 140-230 participants with advanced prostate cancer are planned to be enrolled in this phase. The study will be conducted at multiple investigational sites.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Phase II:
1. Participant laboratory values meet the following requirements:
. Hepatic function assessment:
. Renal function assessment:\*\*
. Hematology assessment:\*\*
. Coagulation assessment:
2. Must agree to use adequate contraception from study initiation through at least 6 months after the last dose of study drug, and must refrain from sperm donation;
3. Able to comply with all study procedures as judged by the investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Radiographic Progression-Free Survival
Timeframe: 24months
2
Recommended Phase 3 Dose（Phase II Cohorts 1, 2, and 3）
. Prior antitumor therapy meets the following conditions:
. Phase Ib:
. Phase II:
. Prior treatment with agents similar to or targeting the same pathway as the study drug (including but not limited to tazemetostat, EZH1/2 inhibitors, and EED inhibitors);
. Received chemotherapy, immunotherapy, definitive radiotherapy, targeted therapy, anti-tumor traditional Chinese medicine, or other anti-tumor therapies within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose; palliative radiotherapy within 2 weeks prior to the first dose;
. Planned receipt of any other anti-tumor therapy during the study period;
. Received any other investigational product not yet approved in the study region within 28 days prior to the first dose of this study (i.e., last dose of investigational product within 28 days of the first study drug dose);
. Presence of central nervous system (CNS) metastases; history of or concurrent CNS conditions including but not limited to epilepsy, paralysis, stroke, severe brain injury, Alzheimer's disease, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, spinal cord compression, or cauda equina syndrome (with the exception of stroke that was adequately treated and stable for ≥12 months prior to first dose, or asymptomatic/untreated lacunar infarction);