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)

Clinical Trial Details

This is a research study to evaluate the safety and tolerability of an experimental drug called TVB-2640 in combination with Enzalutamide for men with metastatic castration resistant prostate cancer (mCRPC) whose disease has progressed while taking androgen-deprivation therapy (ADT). ADT is the primary treatment method for mCRPC. This study will find the highest dose of TVB-2640 that can be given with Enzalutamide without causing severe side effects.

Experimental means that TVB-2640 has not yet been approved by the U.S. Food and Drug Administration (FDA). Enzalutamide is regularly used to treat prostate cancer and is approved by the FDA, however, the combination of these two drugs is not.

All participants will take both study drugs orally in doses determined by the study team. Participants will be expected to record the dates and times they take the study drugs in a drug diary.

Participants will also receive blood draws, imaging scans (PET/CT, CT, MRI), and tumor tissue biopsy throughout the study duration.

Total participation is expected to last about 1-2 years.

Key Eligibility:

Open to men age 18 or above who have a confirmed diagnosis of prostate cancer
Evidence of metastatic prostate cancer on imaging (bone scan and/or CT/MRI scan)
Sexually active, fertile participants and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom with spermicide) during the course of the study and for 4 months after the last dose of study treatment

Detailed eligibility reviewed when participant contacts the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Primary Investigator(s)

David M Nanus, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2208025117

ClinicalTrials.gov:

NCT05743621

Status

Open to Enrollment

Age Group

Adult

Disease

Prostate Cancer