RecruitingPhase 1NCT05743621

Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer

A Phase I, Open-Label, Dose-Finding Study of TVB-2640 Administered in Combination With Enzalutamide (Xtandi) in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)


Sponsor

Weill Medical College of Cornell University

Enrollment

30 participants

Start Date

Nov 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine what effects (good and bad) Enzalutamide and TVB-2640 have in the treatment of prostate cancer whose prostate cancer has spread to other parts of their body and that has not gotten better with previous treatment. This study is a Phase I clinical trial. Phase I clinical trials test the side effects of an investigational drug or an investigational combination with another drug. "Investigational" means that the drug is still being studied and research doctors are trying to find out more about it. Although Enzalutamide is already being used to treat men with prostate cancer, combining Enzalutamide with TVB-2640 together in patients with prostate cancer is considered experimental. This research study is being done because additional effective treatments are needed for prostate cancer that has spread and is growing despite hormone suppression. By doing this study, the investigators hope to learn if combining Enzalutamide with TVB-2640 can be done safely. Participation in this research will last about 12 to 24 months after enrollment.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding TVB-2640 (a drug that blocks a fat-producing enzyme called FASN, which many prostate cancers depend on) to enzalutamide (a standard hormone-blocking drug) can improve outcomes for men with metastatic castration-resistant prostate cancer — meaning the cancer has spread and is no longer responding to standard hormone treatment. **You may be eligible if...** - You are a man over 18 years old with confirmed prostate cancer - Your cancer has spread (metastatic) and is growing despite low testosterone (castration-resistant) - You are planning to start enzalutamide as your first treatment for castration-resistant disease, OR you have previously had only one line of hormone therapy - You are willing to undergo tumor biopsies before and during treatment - Your general health is good (ECOG performance status 0–1) - If you have not had an orchiectomy, you are on testosterone-suppressing injections **You may NOT be eligible if...** - You have already had multiple lines of treatment for castration-resistant prostate cancer - Your organ function (blood, liver, kidneys) is insufficient - You are unable to use contraception during the study 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

DRUGTVB-2640

TVB- 2640 at 100 mg, 150mg, 200 mg, 250 mg, or 300mg daily, orally; dose determined by BOIN dose escalation per the protocol

DRUGEnzalutamide

160 mg daily PO


Locations(1)

Weill Cornell Medicine/NewYork-Presbyterian Hospital

New York, New York, United States

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NCT05743621


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