Study of XNW5004 Tablets in Advanced Prostate Cancer

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

Interventions

DRUG

XNW5004 1200 mg BID in Combination with Abiraterone plus Prednisone

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).

DRUG

XNW5004 1200 mg BID in Combination with Docetaxel plus Prednisone

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.

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

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.

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

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.

DRUG

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

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.

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 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

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

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

Sponsors & Collaborators

• Evopoint Biosciences Inc.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-13

Primary Completion

2028-12-31

Completion

2028-12-31