Actively Recruiting
Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-Resistant Prostate Cancer
Led by Evopoint Biosciences Inc. · Updated on 2025-04-20
307
Participants Needed
2
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this phase Ib/II study, participants with metastatic castration-resistant prostate cancer (mCRPC) who failed prior novel hormone therapy will be treated with XNW5004 in combination with enzalutamide.
CONDITIONS
Official Title
Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be able to understand and sign informed consent.
- Age 18 years or older.
- Life expectancy of at least 3 months.
- ECOG performance status of 0 to 1.
- Confirmed prostate adenocarcinoma (not neuroendocrine or small cell carcinoma).
- Metastatic prostate cancer confirmed by imaging.
- Ongoing medical castration or prior surgical castration with effective hormone therapy maintained.
- Testosterone level at castration range (≤50 ng/dL) at screening.
- Evidence of disease progression by PSA, imaging, or bone scan criteria.
- Prior failure of abiraterone acetate therapy without prior use of next generation androgen receptor inhibitors for parts Ib and IIb.
- Prior failure of only one approved novel hormone therapy excluding enzalutamide for part IIb.
- Adequate blood and organ function during screening.
- Agree to use effective contraception and avoid sperm donation from study start to 3 months after last dose.
- Ability to comply with all study procedures.
You will not qualify if you...
- Previous treatment with next generation androgen receptor antagonists such as enzalutamide for parts Ib and IIb.
- Prior chemotherapy for castration-resistant disease.
- Prior exposure to EZH2 inhibitors.
- Receipt of anti-tumor therapy including chemotherapy, immunotherapy, radiotherapy, major surgery, or targeted therapy within 4 weeks before study drug.
- Participation in other anti-tumor clinical trials within 28 days before study drug.
- Central nervous system metastasis.
- Severe bone injury from tumor metastasis or recent spinal cord compression.
- History of other cancers within 3 years except certain cured skin or bladder cancers.
- Recent stroke or serious cerebrovascular disease within 12 months.
- Serious heart disease or impaired heart function.
- Severe active infections.
- History of tuberculosis within 1 year or untreated active TB.
- Allergy to study drug or ingredients.
- Use of moderate or strong CYP3A inducers or inhibitors within 14 days before dosing.
- Active autoimmune or inflammatory diseases requiring systemic therapy.
- History or evidence of interstitial lung disease or radiation pneumonitis.
- Significant gastrointestinal diseases affecting drug absorption.
- HIV, syphilis positive, or active hepatitis B or C infection.
- Unresolved toxicity from previous anti-tumor treatments above grade 1.
- Uncontrolled pleural or pericardial effusions.
- History of allogeneic tissue or organ transplantation.
- Major surgery within 4 weeks before study or planned during study.
- Live vaccine within 28 days before dosing.
- Superscan on baseline bone scan.
- Any condition judged unsuitable by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Cancer Hosipital of Shandong First Medical University,440 Jiyan Road, Jinan City, Shandong Province
Jinan, Shandong, China, 250117
Actively Recruiting
2
270 Dongan Road, Shanghai
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
J
Junjie Zhang
CONTACT
Q
Qianqian Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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