NCT07104643

Study of TYK-00540 Combined With Enzalutamide in Patients With Metastatic Castration-resistant Prostate Cancer（mCRPC）

A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of TYK-00540 Combined With Enzalutamide in the Treatment of Metastatic Castration-resistant Prostate Cancer (mCRPC) That Has Failed Previous Novel Endocrine Therapy

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: TYK Medicines, Inc · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the safety, and preliminary antitumor activity of TYK-00540 combined with Enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) that have failed novel endocrine therapy

Detailed description

This is an open-label, multi-center, dose-escalation and expansion phase Ib/II study to evaluate dose limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) in subjects with metastatic castration-resistant prostate cancer (mCRPC). To evaluate the efficacy of TYK-00540 combined with Enzalutamide in subjects with metastatic castration-resistant prostate cancer (mCRPC) that have failed novel endocrine therapy

Conditions

• mCRPC

Interventions

Type	Name	Description
DRUG	TYK-00540	Take the specified dose (20mg or 30mg) orally twice a day. Take it on an empty stomach in the morning with about 200 mL of warm water.
DRUG	Enzalutamide	Take orally, 160mg each time, once a day. Take orally with or without meals.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-08-05
• Last updated: 2025-08-05

Locations

1 site across 1 country: China