Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2025-12-27 @ 10:14 PM
Study NCT ID:
NCT06702995
Status:
RECRUITING
Last Update Posted:
2025-04-20
First Post:
2024-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-Resistant Prostate Cancer
Sponsor:
Evopoint Biosciences Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: