Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorWeill Medical College of Cornell University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years
Documented histological or cytological diagnosis of PC
Evidence of metastatic PC on imaging (bone scan and/or CT/MRI scan)
Diagnosis of progressive metastatic, castration resistant prostate cancer
Disqualifiers
Receipt of any type of biologic, or other systemic anticancer therapy (including investigational) except agents within 4 weeks before first dose of study treatment. Anti-resorptive bone agents are also allowed.
Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible.
Prior exposure to taxane chemotherapy
History of pneumonitis
Trial design
Design model
Single group
Treatments tested in this trial
TVB-2640
DrugTVB- 2640 at 100 mg, 150mg, 200 mg, 250 mg, or 300mg daily, orally; dose determined by BOIN dose escalation per the protocol
Enzalutamide
Drug160 mg daily PO
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: TVB-2640 in combination with EnzalutamideExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Optimal dose of TVB-2640 in combination with Enzalutamide, as determined by the maximum tolerated dose (MTD)
The maximum tolerated dose (MTD) is defined as the highest dose level at which ≤1 patient experiences a dose-limiting toxicity, as defined in the protocol (DLT). Once all the patients are accrued, the MTD will be determined by performing isotonic regression on the pooled data.
Time frame
Day 28Secondary outcomes
1
Number of adverse events (evaluated using the NCI CTCAE v5.0) of different doses of TVB-2640 in combination with Enzalutamide
All observed AEs will be tabulated and reported as relative frequencies (i.e., fraction of patients with that AE). This will be done by AE and maximum grade experienced within a patient. The fraction of patients with each AE by grade will be estimated with a binomial point estimate and corresponding 95% binomial confidence interval (CI). AEs will be collected until 30 days following the last dose of study drug. AEs will be reported for each different dose of TVB-2640 given.
Time frame
12 months2
Mean TVB-2640 total exposure (as measured by the area under the drug serum concentration vs. the time from administration curve [AUC])
Peripheral blood will be drawn at: Day 28: * Pre- enza dose * Post-dose * 1 hours (±5 min) * 2 hours (±5 min) * 4 hours (±30 min) Days 36-37: * Pre-TVB-2640 dose * Post-dose * 2 hours (±5 min) * 4 hours (±30 min) * 6 hours (±30 min) * 8 hours (±30 min) * 24-hours (±1 hour) Days 43-44: * Pre-TVB-2640 dose * Post-dose * 30 minutes (±5 min) * 1 hour (±5 min) * 2 hours (±5 min) * 4 hours (±30 min) * 6 hours (±30 min) * 8 hours (±30 min) * 24-hours (±1 hour) Days 50-51: * Pre-TVB-2640 dose * Post-dose * 30 minutes (±5 min) * 1 hour (±5 min) * 2 hours (±5 min) * 4 hours (±30 min) * 6 hours (±30 min) * 8 hours (±30 min) * 24-hours (±1 hour)
Time frame
Day 28; Days 36-37; Days 43-44; Days 50-513
Mean Enzalutamide total exposure (as measured by the area under the drug serum concentration vs. the time from administration curve [AUC])
Peripheral blood will be drawn at: Day 28: * Pre- enza dose * Post-dose * 1 hours (±5 min) * 2 hours (±5 min) * 4 hours (±30 min) Days 36-37: * Pre-TVB-2640 dose * Post-dose * 2 hours (±5 min) * 4 hours (±30 min) * 6 hours (±30 min) * 8 hours (±30 min) * 24-hours (±1 hour) Days 43-44: * Pre-TVB-2640 dose * Post-dose * 30 minutes (±5 min) * 1 hour (±5 min) * 2 hours (±5 min) * 4 hours (±30 min) * 6 hours (±30 min) * 8 hours (±30 min) * 24-hours (±1 hour) Days 50-51: * Pre-TVB-2640 dose * Post-dose * 30 minutes (±5 min) * 1 hour (±5 min) * 2 hours (±5 min) * 4 hours (±30 min) * 6 hours (±30 min) * 8 hours (±30 min) * 24-hours (±1 hour)
Time frame
Day 28; Days 36-37; Days 43-44; Days 50-514
Mean maximum serum concentration (Cmax) of TVB-2640
Peripheral blood will be drawn at the following times: Day 28: * Pre- enza dose * 1 hours (±5 min) post-dose * 2 hours (±5 min) post-dose * 4 hours (±30 min) post-dose Days 36-37: * Before TVB-2640 administration * 2 hours (±5 min) post-dose * 4 hours (±30 min) post-dose * 6 hours (±30 min) post-dose * 8 hours (±30 min) post-dose * 24-hours (±1 hour) post-dose Days 43-44: * Before TVB-2640 administration * 30 minutes (±5 min) post-dose * 1 hour (±5 min) post-dose * 2 hours (±5 min) post-dose * 4 hours (±30 min) post-dose * 6 hours (±30 min) post-dose * 8 hours (±30 min) post-dose * 24-hours (±1 hour) post-dose Days 50-51: * Before TVB-2640 administration * 30 minutes (±5 min) post-dose * 1 hour (±5 min) post-dose * 2 hours (±5 min) post-dose * 4 hours (±30 min) post-dose * 6 hours (±30 min) post-dose * 8 hours (±30 min) post-dose * 24-hours (±1 hour) post-dose
Time frame
Day 28; Days 36-37; Days 43-44; Days 50-51Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
Sagimet Biosciences Inc.
Collaborator
Source ClinicalTrials.gov