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Advanced Prostate CancerPhase 2XNW5004 TabletNCT07730580

Study of XNW5004 Tablets in Advanced Prostate Cancer

A Phase 2 study testing XNW5004 1200 mg BID in Combination with Abiraterone plus Prednisone, XNW5004 1200 mg BID in Combination with Docetaxel plus Prednisone and XNW5004 800 mg or 1200 mg (1:1 randomization), PO, BID; Abiraterone 1000 mg PO, taken on an empty stomach at least 1 hour before and at least 2 hours after a meal, QD; plus Prednisone 5 mg PO BID in people with Advanced Prostate Cancer, run by Evopoint Biosciences Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Advanced Prostate Cancer
What is being tested?
XNW5004 1200 mg BID in Combination with Abiraterone plus Prednisone, XNW5004 1200 mg BID in Combination with Docetaxel plus Prednisone and XNW5004 800 mg or 1200 mg (1:1 randomization), PO, BID; Abiraterone 1000 mg PO, taken on an empty stomach at least 1 hour before and at least 2 hours after a meal, QD; plus Prednisone 5 mg PO BID
Could I receive a placebo?
No, everyone receives an active treatment
How many people
242 participants
Where
No sites listed yet
Study dates
13 Jul 2026to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Participants meeting any of the following criteria will not be eligible for enrollment in this study:
  • Prior antitumor therapy meets the following conditions:
  • Phase Ib:
  • Cohort 1: Prior treatment with abiraterone or cytotoxic chemotherapy (including but not limited to antibody-drug conjugates [ADCs] with cytotoxic payload). *Note:* Docetaxel use during the hormone-sensitive setting is allowed, provided there was no treatment failure or disease progression during therapy or within 3 months after completion.
  • Cohort 2: Prior cytotoxic chemotherapy (including but not limited to ADCs with cytotoxic payload) at any stage of prostate cancer. *Note:* Docetaxel use during the hormone-sensitive setting is allowed, provided there was no treatment failure or disease progression during therapy or within 3 months after completion.
  • Phase II:
Show all 40Show fewer
  • Cohort 1: Prior treatment with abiraterone or cytotoxic chemotherapy (including but not limited to ADCs with cytotoxic payload). *Note:* Docetaxel use during the hormone-sensitive setting is allowed, provided there was no treatment failure or disease progression during therapy or within 3 months after completion.
  • Cohort 2:Participants must be treatment-naïve in the metastatic castration-sensitive prostate cancer (mCSPC) setting; i.e., participants must not have received any cytotoxic chemotherapy (including but not limited to ADCs with cytotoxic payload), with the exception that first-generation antiandrogen (ADT) therapy is allowed during the mCSPC stage.
  • Cohort 3:Participants must not have received any cytotoxic chemotherapy (including but not limited to ADCs with cytotoxic payload). *Note:* Docetaxel use during the hormone-sensitive setting is allowed, provided there was no treatment failure or disease progression during therapy or within 3 months after completion.
  • Cohort 4: Participants must be treatment-naïve in the metastatic castration-sensitive prostate cancer (mCSPC) setting; i.e., participants must not have received any cytotoxic chemotherapy (including but not limited to ADCs with cytotoxic payload), with the exception that first-generation antiandrogen (ADT) therapy is allowed during the mCSPC stage.
  • 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);
  • Severe bone damage due to tumor bone metastases as judged by the investigator, including poorly controlled severe bone pain, pathological fractures at critical sites occurring within the last 6 months or expected in the near future, and spinal cord compression;
  • History of other malignancy within 3 years prior to enrollment that does not meet clinical cure criteria. Exceptions: basal cell carcinoma or squamous cell carcinoma of the skin that has been locally treated and cured, superficial bladder cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma;
  • Poorly controlled bladder outlet obstruction or urinary incontinence as judged by the investigator;
  • Impaired cardiac function or clinically significant cardiac disease, including any of the following:
  • Acute myocardial infarction or unstable angina ≤ 6 months prior to first dose;
  • Congestive heart failure (New York Heart Association [NYHA] Class III or IV), left ventricular ejection fraction (LVEF) < 50%;
  • Uncorrected serious arrhythmia, hypertension ≥ 150/100 mmHg;
  • Prolonged QTc interval (defined as >450 ms for males, >470 ms for females) per Fridericia's formula (see Appendix 20.4);
  • History of other major cardiovascular disease (e.g., valve replacement, coronary artery bypass grafting, etc.);
  • Active systemic severe infection: a washout period of at least 2 weeks is required after completion of antifungal therapy (whether intravenous or oral); at least 1 week washout after completion of other intravenous anti-infective therapy; other oral anti-infective therapy must meet discontinuation criteria and be stopped prior to the first study dose;
  • History of tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year ago without adequate anti-tuberculosis treatment;
  • Known hypersensitivity to the study drug or its active ingredients or excipients;
  • Use of known moderate or strong CYP3A inducers or inhibitors within 14 days prior to the first dose (see Appendix 20.5);
  • Active autoimmune and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic therapy, rheumatoid arthritis, inflammatory bowel disease, and Hashimoto's thyroiditis; with the exception of Type 1 diabetes mellitus, hypothyroidism controlled solely by replacement therapy, hyperthyroidism stable on medication, and skin conditions not requiring systemic therapy (e.g., vitiligo, localized psoriasis);
  • History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active ILD;
  • Known gastrointestinal (GI) function impairment or GI conditions that may significantly affect the absorption or metabolism of oral medications; abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose;
  • Human immunodeficiency virus (HIV) positive, or syphilis (Anti-TP) positive (not excluded if non-treponemal syphilis test is negative and the investigator determines syphilis has been cured);
  • Known acute or chronic active hepatitis B (HBsAg positive or HBcAb positive with HBV DNA ≥ 200 IU/mL or ≥ 10³ copies/mL), or acute or chronic active hepatitis C (HCV antibody positive with HCV RNA positive);
  • Toxicities from prior anti-tumor therapy that have not resolved (not recovered to ≤ Grade 1 per NCI-CTCAE Version 6.0). Exceptions include other toxicities that the investigator deems do not affect participant safety assessment (e.g., alopecia);
  • Symptomatic pleural effusion, ascites, or pericardial effusion that is poorly controlled despite repeated treatment;
  • Prior allogeneic tissue or solid organ transplantation;
  • Major surgery within 4 weeks prior to dosing, or planned major surgery during the study period (excluding procedures such as puncture or lymph node biopsy);
  • Received live virus vaccine (including live attenuated vaccine) within 28 days prior to dosing; inactivated vaccines are allowed;
  • Baseline bone scan showing a "superscan" pattern that precludes assessment of new bone metastases;
  • Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Junjie Zhang Central Contact Person contact

86+15010250838

junjie.zhang@evopointbio.com

About this study

Official title: An Open-Label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of XNW5004 Tablets in Combination With Anti-Tumor Therapy in Participants With Advanced Prostate Cancer

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.

Read the detailed description

This study consists of two phases. The first phase (Phase Ib) is a safety lead-in study of XNW5004 in combination with anti-tumor therapy; the second phase (Phase II) is a dose expansion study of XNW5004 in combination with anti-tumor therapy.

Phase Ib is a non-randomized, open-label study. Given the differences in mechanism of action, pharmacokinetic profiles, and toxicity profiles when XNW5004 is combined with different anti-tumor agents, the safety lead-in will be conducted independently for each combination cohort.

Upon completion of the Cycle 1 safety evaluation for the corresponding cohort in Phase Ib, the Phase II study will be initiated. Phase II is a randomized, open-label, dose expansion study. A preliminary design of 5 cohorts will further evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of XNW5004 in combination with anti-tumor therapy in participants with advanced prostate cancer.

The study process includes a screening period, a treatment period, and a follow-up period. Eligible participants after screening will enter the treatment period and receive therapy according to the combination regimen of their assigned cohort, until disease progression, death, withdrawal of informed consent, intolerable toxicity, or any other condition that the investigator deems necessary for study discontinuation.

Participants will undergo PK and PD blood sampling at designated time points, and relevant anti-tumor efficacy assessments will be performed.

Being tested
XNW5004 1200 mg BID in Combination with Abiraterone plus Prednisone, XNW5004 1200 mg BID in Combination with Docetaxel plus Prednisone, XNW5004 800 mg or 1200 mg (1:1 randomization), PO, BID; Abiraterone 1000 mg PO, taken on an empty stomach at least 1 hour before and at least 2 hours after a meal, QD; plus Prednisone 5 mg PO BID, XNW5004 800 mg or 1200 mg (1:1 randomization), PO, BID; Abiraterone 1000 mg PO, taken on an empty stomach at least 1 hour before and at least 2 hours after a meal, QD; plus Prednisone 5 mg PO, QDD, XNW5004 800/1200 mg BID in Combination with Docetaxel plus Prednisone
Keywords
XNW5004, Advanced Prostate Cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XNW5004 1200 mg BID in Combination with Abiraterone plus PrednisoneDrug

    Ib Cohort 1: XNW5004 1200 mg, PO, BID (10-14 hours interval between two doses, taken with warm water); Abiraterone 1000 mg PO, taken on an empty stomach at least 1 hour before and at least 2 hours after a meal, QD; Prednisone 5 mg PO, BID (prednisone dosing frequency may be adjusted at the investigator's discretion).

  • XNW5004 1200 mg BID in Combination with Docetaxel plus PrednisoneDrug

    Ib Cohort 2: XNW5004 1200 mg, PO, BID (10-14 hours interval between two doses, taken with warm water), administered continuously until disease progression, death, withdrawal of informed consent, intolerable toxicity, or any other condition that the investigator deems necessary for study discontinuation. Docetaxel 75 mg/m², intravenous (IV), Day 1; Prednisone tablets 5 mg, PO, BID, taken continuously.

  • XNW5004 800 mg or 1200 mg (1:1 randomization), PO, BID; Abiraterone 1000 mg PO, taken on an empty stomach at least 1 hour before and at least 2 hours after a meal, QD; plus Prednisone 5 mg PO BIDDrug

    XNW5004 800 mg or 1200 mg (1:1 randomization), PO, BID; Abiraterone 1000 mg PO, taken on an empty stomach at least 1 hour before and at least 2 hours after a meal, QD; plus Prednisone 5 mg PO, BID or QD.

    Required first-dose sequence on Day 1 and Day 28 of Cycle 1 for the first 10 participants in each dose cohort: Take abiraterone first; consume a meal 1 hour after abiraterone administration; take XNW5004 tablets plus prednisone simultaneously 1.5 hours after abiraterone administration.

  • XNW5004 800 mg or 1200 mg (1:1 randomization), PO, BID; Abiraterone 1000 mg PO, taken on an empty stomach at least 1 hour before and at least 2 hours after a meal, QD; plus Prednisone 5 mg PO, QDDDrug

    XNW5004 800 mg or 1200 mg (1:1 randomization), PO, BID; Abiraterone 1000 mg PO, taken on an empty stomach at least 1 hour before and at least 2 hours after a meal, QD; plus Prednisone 5 mg PO, QD.

    Required first-dose sequence on Day 1 and Day 28 of Cycle 1 for the first 10 participants in each dose cohort: Take abiraterone first; consume a meal 1 hour after abiraterone administration; take XNW5004 tablets plus prednisone simultaneously 1.5 hours after abiraterone administration.

  • XNW5004 800/1200 mg BID in Combination with Docetaxel plus PrednisoneDrug

    XNW5004 800 mg or 1200 mg (1:1 randomization), PO, BID, administered continuously until disease progression, death, withdrawal of informed consent, intolerable toxicity, or any other condition that the investigator deems necessary for study discontinuation. Docetaxel 75 mg/m², intravenous (IV), Day 1 (premedication prior to docetaxel administration shall follow the prescribing information and standard clinical practice of the study center); plus Prednisone tablets 5 mg, PO, BID, taken continuously.

  • XNW5004 1200 mg, PO, BID (10-14 hours interval between two doses, taken with warm water); Enzalutamide 160 mg, PO, QD. Each treatment cycle consists of 4 weeks.Drug

    XNW5004 1200 mg, PO, BID (10-14 hours interval between two doses, taken with warm water); Enzalutamide 160 mg, PO, QD. Each treatment cycle consists of 4 weeks.

  • Subsequent development plans will be determined based on preliminary study results.Drug

    Subsequent development plans will be determined based on preliminary study results.

Study groups in NCT07730580
Study groupRoleWhat they receive
mCRPC (Prior NHT Failure Excluding Abiraterone) - XNW5004 + Abiraterone + PrednisoneExperimentalParticipants with metastatic castration-resistant prostate cancer (mCRPC) who have previously failed novel hormonal therapy other than abiraterone acetate will be enrolled.
Receives: Drug: XNW5004 1200 mg BID in Combination with Abiraterone plus Prednisone
mCRPC with Prior NHT Failure - XNW5004 + Docetaxel + PrednisoneExperimentalParticipants with mCRPC who have failed at least one prior line of novel hormonal therapy will be enrolled.
Receives: Drug: XNW5004 1200 mg BID in Combination with Docetaxel plus Prednisone
Randomized mCRPC (Prior NHT Failure Excluding Abiraterone) - XNW5004 + Abiraterone + PrednisoneActive comparatorParticipants with metastatic castration-resistant prostate cancer (mCRPC) who have failed prior novel hormonal therapy other than abiraterone acetate will be enrolled.
Receives: Drug: XNW5004 800 mg or 1200 mg (1:1 randomization), PO, BID; Abiraterone 1000 mg PO, taken on an empty stomach at least 1 hour before and at least 2 hours after a meal, QD; plus Prednisone 5 mg PO BID
mCSPCActive comparatorParticipants with mCRPC who have failed at least one prior line of novel hormonal therapy are eligible for enrollment.
Receives: Drug: XNW5004 800 mg or 1200 mg (1:1 randomization), PO, BID; Abiraterone 1000 mg PO, taken on an empty stomach at least 1 hour before and at least 2 hours after a meal, QD; plus Prednisone 5 mg PO, QDD
Randomized mCRPC (Prior NHT Failure) - XNW5004 + Docetaxel + PrednisoneActive comparatorParticipants with mCRPC who have failed at least one prior line of novel hormonal therapy will be enrolled.
Receives: Drug: XNW5004 800/1200 mg BID in Combination with Docetaxel plus Prednisone
mCSPC Treated with XNW5004 in Combination with EnzalutamideExperimentalParticipants with mCSPC will be enrolled and will receive XNW5004 in combination with enzalutamide.
Receives: Drug: XNW5004 1200 mg, PO, BID (10-14 hours interval between two doses, taken with warm water); Enzalutamide 160 mg, PO, QD. Each treatment cycle consists of 4 weeks.
XNW5004 + Anti-Tumor TherapyExperimentalParticipants with advanced prostate cancer will be enrolled and will receive XNW5004 in combination with other anti-tumor therapies. The subsequent development plan for this cohort will be determined based on results from prior study phases.
Receives: Drug: Subsequent development plans will be determined based on preliminary study results.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic Progression-Free Survival

    Measured: 24months

  2. Recommended Phase 3 Dose（Phase II Cohorts 1, 2, and 3）

    Measured: 24 months

Secondary outcomes (22)

  1. Time to PSA Progression

    Measured: 24 months

  2. PSA Response Rate at Week 12

    Measured: 24 months

  3. Proportion of Participants with PSA Reduction ≥50% from Baseline During Entire Treatment Period

    Measured: 24 months

  4. Time to First Symptomatic Skeletal Event

    Measured: 24 months

  5. Objective Response Rate (ORR) per RECIST 1.1 and PCWG3

    Measured: 24 months

  6. Disease Control Rate (DCR) per RECIST 1.1 and PCWG3

    Measured: 24 months

  7. Duration of Response (DOR) per RECIST 1.1 and PCWG3

    Measured: 24 months

  8. Overall Survival (OS) per RECIST 1.1 and PCWG3

    Measured: 24 months

  9. Safety Endpoints:Incidence of Adverse Events

    Measured: 24 months

  10. Safety Endpoints:Severity of Adverse Events

    Measured: 24 months

  11. Safety Endpoints:Abnormal Laboratory Parameters

    Measured: 24 months

  12. Area under the plasma concentration-time curve (AUC)

    Measured: 24 months

  13. Maximum (Peak) Plasma Concentration (Cmax)

    Measured: months

  14. Maximum (Peak) Plasma Concentration at Steady State (Css,max)

    Measured: 24 months

  15. Area under the plasma concentration-time curve at Steady State (AUCss)

    Measured: 24 months

  16. Time to Peak Concentration (Tmax)

    Measured: 24 months

  17. Elimination Half-Life (t₁/₂)

    Measured: 24 months

  18. Mean Residence Time (MRT)

    Measured: 24 months

  19. Apparent Volume of Distribution at Terminal Phase (Vz/F)

    Measured: 24 months

  20. Apparent Clearance (CL/F)

    Measured: 24 months

  21. Accumulation Ratio (Rac)

    Measured: 24 months

  22. Change from Baseline in H3K27me3 / Histone H3 Ratio

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2026
  2. Study start13 Jul 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
242 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07730580
Sponsor's protocol ID
XNW5004-Ib/II-07
Acronym
XNW5004 Tablet
Status last verified
Jul 2026
First submitted
16 Jul 2026
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing XNW5004 1200 mg BID in Combination with Abiraterone plus Prednisone, XNW5004 1200 mg BID in Combination with Docetaxel plus Prednisone and XNW5004 800 mg or 1200 mg (1:1 randomization), PO, BID; Abiraterone 1000 mg PO, taken on an empty stomach at least 1 hour before and at least 2 hours after a meal, QD; plus Prednisone 5 mg PO BID in people with Advanced Prostate Cancer, run by Evopoint Biosciences Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Junjie Zhang Central Contact Person (86+15010250838, junjie.zhang@evopointbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression-Free Survival (time frame: 24months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07730580.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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