Actively Recruiting
Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer
Led by Weill Medical College of Cornell University · Updated on 2025-11-21
30
Participants Needed
1
Research Sites
270 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
S
Sagimet Biosciences Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Histological or cytological diagnosis of prostate cancer
- Evidence of metastatic prostate cancer on bone scan or CT/MRI scan
- Diagnosis of progressive metastatic castration-resistant prostate cancer
- Planning to receive Enzalutamide as first-line therapy for castration-resistant prostate cancer or having received up to one prior line of Abiraterone or an androgen receptor antagonist
- Willing to undergo a tumor biopsy before starting therapy if recent tissue samples are not available
- Willing to have a tumor biopsy of at least one metastatic site or the primary prostate after about 4-6 weeks of therapy with both drugs
- If no prior orchiectomy, willing to continue luteinizing hormone-releasing hormone analogue therapy during study treatment
- ECOG performance status of 0 or 1
- Recovery to baseline or Grade 1 or less from prior treatment toxicities, unless stable and clinically nonsignificant
- Adequate organ and marrow function based on labs within 14 days before first study dose
- Sexually active, fertile participants and partners agree to use medically accepted contraception during and for 4 months after treatment
- Capable of understanding and complying with study requirements and have signed informed consent
You will not qualify if you...
- Received any biologic or systemic anticancer therapy (including investigational) within 4 weeks before first study dose, except anti-resorptive bone agents
- Radiation therapy for bone metastasis within 2 weeks or other radiation therapy within 4 weeks before first study dose
- Systemic radionuclide treatment within 6 weeks before first study dose
- Ongoing complications from prior radiation therapy
- Prior exposure to taxane chemotherapy
- History of pneumonitis
- Known brain metastases or cranial epidural disease unless treated and stable for at least 4 weeks before first study dose
- Clinically significant dry eye or corneal abnormalities
- Taking certain anticoagulants such as warfarin, dabigatran, betrixaban, or clopidogrel
- Prothrombin time/INR or partial thromboplastin time test 1.3 times or more above normal within 30 days before first study dose
- Use of strong CYP2C8 or P-gp inhibitors, strong CYP3A4 or CYP2C8 inducers, or strong CYP3A4, CYP2C9, CYP2C19 substrates unless necessary and discussed with Medical Monitor
- Uncontrolled cardiovascular conditions including severe heart failure, unstable angina, serious arrhythmias, uncontrolled hypertension, recent stroke or heart attack within 6 months
- Corrected QT interval over 470 ms on ECG within 28 days before first study dose
- Inability to swallow tablets
- Use of herbal products that lower PSA within 4 weeks before enrollment
- Allergy or hypersensitivity to study drug components
- Diagnosis of another cancer within 2 years before first study dose except certain low-grade or superficial skin cancers
- Serious or unstable medical or psychiatric disorders that interfere with safety or study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York, United States, 10021
Actively Recruiting
Research Team
G
GUONC Research Team
CONTACT
E
Escarleth Fernandez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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