RecruitingPhase 1Phase 2NCT06457919

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)

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

50 participants

Start Date

Jun 4, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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).

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called tinengotinib (TT-00420) in combination with standard treatments for men with metastatic prostate cancer (prostate cancer that has spread to other parts of the body, most often the bones). **You may be eligible if...** - You are 18 or older - You have been diagnosed with prostate cancer confirmed by biopsy - Your cancer has spread, with at least 2 bone lesions visible on a bone scan, or soft tissue spread visible on CT or MRI - You are receiving or have received standard prostate cancer treatments **You may NOT be eligible if...** - Your cancer spread is only visible on PET scans (not confirmed by CT, MRI, or bone scan) - You have pure small cell carcinoma of the prostate - You do not meet the performance status or other medical eligibility criteria 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

DRUGTinengotinib

Tinengotinib will be administered daily for 28-day cycles. A flat dose of 10 mg PO once daily.

DRUGabiraterone acetate with prednisone

Abiraterone acetate 1000 mg PO QD in combination with prednisone 5 mg PO once or twice daily (QD or BID)

DRUGEnzalutamide

Enzalutamide 160 mg PO QD

Locations(12)

Yale University (Data Collection Only)

New Haven, Connecticut, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Columbia University

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Duke University

Durham, North Carolina, United States

Oregon Health & Science University

Portland, Oregon, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT06457919

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