NCT06457919

A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer

A Phase 1b/2 Study Evaluating the Activity of Tinengotinib (TT-00420) in Combination With Androgen Receptor Signaling Inhibitors (ARSIs) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether tinengotinib in combination with abiraterone acetate and prednisone or enzalutamide is a safe treatment that causes few or mild side effects in people with metastatic castration-resistant prostate cancer (mCRPC).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Tinengotinib	Tinengotinib will be administered daily for 28-day cycles. A flat dose of 10 mg PO once daily.
DRUG	abiraterone acetate with prednisone	Abiraterone acetate 1000 mg PO QD in combination with prednisone 5 mg PO once or twice daily (QD or BID)
DRUG	Enzalutamide	Enzalutamide 160 mg PO QD

Timeline

• Start date: 2024-06-04
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2024-06-13
• Last updated: 2026-03-24

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study