Actively Recruiting
A Phase I, Open-Label, Dose-Finding Study of TVB-2640 Combined With Enzalutamide 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
104 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
Researchers are evaluating the effects of combining Enzalutamide and TVB-2640 in treating men with metastatic castration-resistant prostate cancer, a form of prostate cancer that has spread and no longer responds to hormone therapy. This phase I clinical trial aims to determine the safety, side effects, and optimal dose of this new drug combination, as current treatments have limited effectiveness. The study is important because it explores a new potential treatment for prostate cancer that continues to grow despite hormone suppression. Participants will first receive Enzalutamide alone at a daily dose of 160 mg for 28 days to reach steady drug levels. After this run-in period, they will begin oral TVB-2640 at an initial dose of 100 mg daily. The dose of TVB-2640 may be gradually increased through several levels up to 300 mg daily, following a specific dose escalation plan to find the maximum tolerated dose. This is the first clinical test of TVB-2640 combined with Enzalutamide in prostate cancer patients. During the study, participants will undergo regular assessments including imaging scans, blood tests to monitor drug levels and prostate-specific antigen (PSA), and tumor biopsies before and after treatment. Researchers will track side effects, drug exposure, and cancer progression over a period of about 12 to 24 months after enrollment. Safety and effectiveness will be closely monitored to guide further research and potential future treatments.
CONDITIONS
Brief 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
- Confirmed diagnosis of prostate cancer by tissue examination
- Evidence of metastatic prostate cancer on imaging scans
- Diagnosis of progressive metastatic castration-resistant prostate cancer
- Planning to receive Enzalutamide as first therapy for castration-resistant prostate cancer or previously received up to one line of Abiraterone or androgen receptor antagonist
- Willing to have a tumor biopsy before starting therapy if recent samples are unavailable
- Willing to have a tumor biopsy after 4-6 weeks of combined therapy
- If no prior orchiectomy, currently taking and willing to continue hormone therapy with LHRH analogues
- ECOG performance status of 0 or 1
- Recovery to baseline or Grade 1 or less from prior treatment toxicities unless stable on supportive therapy
- Adequate organ and marrow function based on recent lab tests
- Sexually active and fertile participants and partners agree to use contraception during and for 4 months after treatment
- Able to understand and comply with study requirements and provide informed consent
You will not qualify if you...
- Received systemic anticancer therapy other than allowed agents within 4 weeks before study treatment
- Radiation therapy for bone metastasis within 2 weeks or other radiation within 4 weeks before study treatment
- Use of radionuclide therapy within 6 weeks before study treatment
- Prior taxane chemotherapy
- History of pneumonitis
- Known brain metastases or cranial epidural disease unless treated and stable for at least 4 weeks
- Clinically significant dry eye or corneal abnormalities
- Current use of certain anticoagulation medications like warfarin or dabigatran
- Prothrombin time or partial thromboplastin time tests greater than 1.3 times normal within 30 days before treatment
- Use of strong CYP enzyme inhibitors or inducers unless managed carefully
- Uncontrolled significant cardiovascular disorders including severe heart failure, unstable angina, serious arrhythmias, uncontrolled hypertension, recent stroke or heart attack within 6 months
- Corrected QT interval greater than 470 ms on ECG within 28 days before treatment
- Inability to swallow tablets
- Use of herbal products that may lower PSA within 4 weeks before enrollment
- Allergy or hypersensitivity to study drug components
- Diagnosis of another cancer within 2 years except certain low-risk skin or tumors
- Serious or unstable medical or psychiatric conditions affecting safety or study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants will receive Enzalutamide monotherapy daily for 28 days to reach steady state before starting combination therapy.
1 baseline visit and multiple visits during the 28-day period
Duration - Treatment duration varies with dose escalation until maximum tolerated dose or discontinuation.
Participants receive oral TVB-2640 daily at doses determined by a dose-escalation scheme combined with daily Enzalutamide.
Multiple visits during treatment including assessments on Days 28, 36-37, 43-44, and 50-51
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
E
Escarleth Fernandez
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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