This is a Phase 1, open-label study that will evaluate the safety and tolerability of FT-7051 and determine the recommended Phase 2 dose (RP2D) as well as pharmacokinetics (PK), preliminary anti-tumor activity, and pharmacodynamics (PD) of FT-7051 in men with metastatic castration-resistant prostate cancer who have progressed despite prior therapy and had been treated with at least one potent anti-androgen therapy. The starting dose, 25 mg once daily (QD), of FT-7051 administered discontinuously (21 days on/7 days off) in 28-day cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Dose levels: Dose Level -1 through Dose Level 7, assigned per the protocol using a BOIN design. Additional dose levels may be explored as applicable. Capsules available in strengths of 10mg, 25mg, and 100 mg that are orally administered per the protocol frequency and dose level.
HonorHealth
Scottsdale, Arizona, United States
University of Colorado Health
Aurora, Colorado, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
University of Maryland, Greenebaum Cancer Center
Incidence of dose limiting toxicities (DLTs)
Time frame: Within first 4 weeks of treatment
Serious adverse events (SAEs) and clinically relevant adverse events (AEs)
Time frame: The treatment duration, predicted average 26 weeks
Incidence of clinical laboratory abnormalities as assessed by CTCAE v5.0
Time frame: The treatment duration, predicted average 26 weeks
Prostate-specific antigen (PSA): Percent Change from Baseline
Time frame: 12 weeks
Prostate-specific antigen (PSA): Maximum Decrease from Baseline
Time frame: The treatment duration, predicted average 26 weeks
Prostate-specific antigen (PSA): Time to Progression
Time frame: The treatment duration, predicted average 26 weeks
Time to radiographic progression (rTTP)
Time frame: The treatment duration, predicted average 26 weeks
Overall response rate: radiographic response rate
Time frame: The treatment duration, predicted average 26 weeks
Complete response rate
Time frame: The treatment duration, predicted average 26 weeks
Area under the plasma concentration versus time curve (AUC)
Time frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
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Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
Duke University Health System
Durham, North Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Peak Plasma Concentration (Cmax)
Time frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Time of peak plasma concentration (Tmax)
Time frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Terminal elimination half-life (T 1/2)
Time frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Apparent plasma clearance (CL/F)
Time frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Apparent volume of distribution (Vd/F)
Time frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Model-based estimate of change from baseline QT interval corrected using Fridericia's correction formula (QTcF) and 90% confidence interval at the estimated Cmax
Time frame: Electrocardiogram collected at multiple timepoints during the first 45 days of treatment