RecruitingPhase 1Phase 2NCT06702995

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


Sponsor

Evopoint Biosciences Inc.

Enrollment

307 participants

Start Date

Apr 19, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called XNW5004 in combination with enzalutamide for men with metastatic castration-resistant prostate cancer — meaning the cancer has spread and is no longer responding to hormone therapy that lowers testosterone. **You may be eligible if...** - You are 18 or older with a life expectancy of at least 3 months - You have prostate cancer confirmed by biopsy that has spread to other parts of the body - Your testosterone is at castration levels (very low) due to medication or surgery - Your cancer has progressed despite hormone therapy - You have previously been treated with abiraterone acetate and it stopped working **You may NOT be eligible if...** - You have a type of prostate cancer other than adenocarcinoma (such as small cell or neuroendocrine) - Your general health is poor (ECOG performance status above 1) - You have not had prior abiraterone treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXNW5004

Oral continuous

DRUGenzalutamide

enzalutamide 160 mg (four 40 mg capsules) orally once daily


Locations(2)

Cancer Hosipital of Shandong First Medical University,440 Jiyan Road, Jinan City, Shandong Province

Jinan, Shandong, China

270 Dongan Road, Shanghai

Shanghai, Shanghai Municipality, China

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NCT06702995


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