Study of XNW5004 Tablets in Advanced Prostate Cancer

NCT07730580 | Not Yet Recruiting Phase 2

• 1 other identifier: XNW5004-Ib/II-07
• Study Type: interventional
• Target: 242
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced Prostate Cancer

Keywords

XNW5004; Advanced Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Radiographic Progression-Free Survival

  24months

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

  24 months

Secondary Outcomes (22)

• Time to PSA Progression

  24 months

• PSA Response Rate at Week 12

  24 months

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

  24 months

• Time to First Symptomatic Skeletal Event

  24 months

• Objective Response Rate (ORR) per RECIST 1.1 and PCWG3

  24 months

Other Outcomes (1)

• Retrospective Analysis of Correlation Between Biomarkers (Including AR-V7) and Efficacy

  24 months

Study Arms (7)

mCRPC (Prior NHT Failure Excluding Abiraterone) - XNW5004 + Abiraterone + Prednisone

EXPERIMENTAL

Participants with metastatic castration-resistant prostate cancer (mCRPC) who have previously failed novel hormonal therapy other than abiraterone acetate will be enrolled.

Drug: XNW5004 1200 mg BID in Combination with Abiraterone plus Prednisone

mCRPC with Prior NHT Failure - XNW5004 + Docetaxel + Prednisone

EXPERIMENTAL

Participants with mCRPC who have failed at least one prior line of novel hormonal therapy will be enrolled.

Drug: XNW5004 1200 mg BID in Combination with Docetaxel plus Prednisone

Randomized mCRPC (Prior NHT Failure Excluding Abiraterone) - XNW5004 + Abiraterone + Prednisone

ACTIVE COMPARATOR

Participants with metastatic castration-resistant prostate cancer (mCRPC) who have failed prior novel hormonal therapy other than abiraterone acetate will be enrolled.

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

mCSPC

ACTIVE COMPARATOR

Participants with mCRPC who have failed at least one prior line of novel hormonal therapy are eligible for enrollment.

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 + Prednisone

ACTIVE COMPARATOR

Participants with mCRPC who have failed at least one prior line of novel hormonal therapy will be enrolled.

Drug: XNW5004 800/1200 mg BID in Combination with Docetaxel plus Prednisone

mCSPC Treated with XNW5004 in Combination with Enzalutamide

EXPERIMENTAL

Participants with mCSPC will be enrolled and will receive XNW5004 in combination with enzalutamide.

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 Therapy

EXPERIMENTAL

Participants 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.

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

Interventions

XNW5004 1200 mg BID in Combination with Abiraterone plus Prednisone DRUG

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).

mCRPC (Prior NHT Failure Excluding Abiraterone) - XNW5004 + Abiraterone + Prednisone

XNW5004 1200 mg BID in Combination with Docetaxel plus Prednisone DRUG

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.

mCRPC with Prior NHT Failure - XNW5004 + Docetaxel + 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 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 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.

Randomized mCRPC (Prior NHT Failure Excluding Abiraterone) - XNW5004 + Abiraterone + 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, QDD 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, 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.

mCSPC

XNW5004 800/1200 mg BID in Combination with Docetaxel plus Prednisone DRUG

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.

Randomized mCRPC (Prior NHT Failure) - XNW5004 + Docetaxel + Prednisone

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.

mCSPC Treated with XNW5004 in Combination with Enzalutamide

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

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

XNW5004 + Anti-Tumor Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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:
• 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);

Sponsors & Collaborators

• Evopoint Biosciences Inc.: lead

MeSH Terms

Interventions

BID protein, human; abiraterone; Prednisone; Docetaxel; Random Allocation; Lead; Postprandial Period; enzalutamide

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Metals, Heavy; Elements; Inorganic Chemicals; Metals; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Junjie Zhang Central Contact Person

CONTACT

86+15010250838; junjie.zhang@evopointbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 28, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share