NCT06702995

Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-Resistant Prostate Cancer

A Phase Ib/II Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Failed Prior Novel Hormone Therapy

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 307 (estimated)
• Sponsor: Evopoint Biosciences Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a multicenter, phase Ib/II clinical trial, divided into three parts: The part1 is the dose escalation study of XNW5004 combined with Enzalutamide (Dose escalation in phase Ib) . The part2 is the dose expansion study of XNW5004 combined with Enzalutamide (Dose expansion in phase IIa). The phase Ib and IIa will evaluate the safety, tolerability and preliminary anti-tumor activity of XNW5004 in combination with enzalutamide to determine the recommended phase II dose (RP2D). The part3 is an open label, randomized phase 2 study (Phase IIb). The patients with mCRPC will be enrolled to assess the efficacy of XNW5004 at the RP2D in combination with Enzalutamide in comparison with Enzalutamide alone.

Conditions

• Metastatic Castrate-Resistant Prostate Cancer
• mCRPC (Metastatic Castration-resistant Prostate Cancer)

Interventions

Type	Name	Description
DRUG	XNW5004	Oral continuous
DRUG	enzalutamide	enzalutamide 160 mg (four 40 mg capsules) orally once daily

Timeline

• Start date: 2023-04-19
• Primary completion: 2026-05-13
• Completion: 2026-07-19
• First posted: 2024-11-25
• Last updated: 2025-04-20

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study