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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT05743621
Phase
PHASE1
Status
Recruiting
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Conditions

  • Prostatic Neoplasms, Castration-Resistant

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TVB-2640 — DRUG
    TVB- 2640 at 100 mg, 150mg, 200 mg, 250 mg, or 300mg daily, orally; dose determined by BOIN dose escalation per the protocol
  • Enzalutamide — DRUG
    160 mg daily PO

Study Details

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.

Key Dates

Start date
Nov 20, 2023
Status verified
Nov 2025
Primary completion
Jan 25, 2027
Completion
Jan 25, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TVB-2640 in combination with Enzalutamide

Primary Outcome Measure

Optimal dose of TVB-2640 in combination with Enzalutamide, as determined by the maximum tolerated dose (MTD) [ Time Frame: Day 28 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medicine/NewYork-Presbyterian HospitalNew YorkNew York10021
Escarleth Fernandez
[email protected]
646-962-9406
Sarah Yuan
[email protected]
David Nanus, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Weill Cornell Medicine/NewYork-Presbyterian Hospital· New York, NY

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