A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF PF-07225570 EITHER ALONE OR IN COMBINATION WITH AN ANTI-PD-1 ANTIBODY, IN PARTICIPANTS WITH RECURRENT NON-MUSCLE INVASIVE BLADDER CANCER

简要总结

主要结局

次要结局

• Urine PF-07225570 concentration after a single dose(Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 0-2 hours, and 4 - 6 hours post-instillation on Cycle 1 Day 1)
• Durability of complete responses (CRs) as measured from time of documented CR to time of high-grade tumor recurrence, disease progression, or death (whichever occurs first) in participants who achieved a CR(Baseline up to 24 months)
• Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07225570 after a single dose(Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 0.5, 1, 2, 3, 4, 6 and 24 hours after instillation)
• Concentration from maximum to steady state (Cmax,ss) of PF-07225570 after multiple doses(Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 2 hours after instillation)
• Incidence of Radical Cystectomy(Baseline up to 24 months)
• Serum sasanlimab concentrations(Pre-dose (within 6 hours) before each administration)
• For participants with high-grade Ta/ T1 disease only, Proportion of participants without high-grade-recurrence at each assessment visit.(Baseline up to 24 months)
• Area under the curve from specified time to steady state (AUCτ,ss) of PF-07225570 after multiple doses(Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 2 hours after instillation)
• Progression-Free Survival(Baseline up to 24 months)
• Proportion of participants with carcinoma in situ (CIS) achieving complete response at any time after first dose of PF 07225570(Baseline up to 24 months)
• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-07225570 after a single dose(Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 0.5, 1, 2, 3, 4, 6 and 24 hours after instillation)
• Urine PF-07225570 concentration after multiple doses(Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 0-2 hours and 2 - 4 hours post-instillation.)
• Incidence and titers of neutralizing antibodies (NAb) against sasanlimab(Pre-dose (within 6 hours) before each administration)
• Maximum Observed Plasma Concentration (Cmax) of PF-7225570 after a single dose(Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 0.5, 1, 2, 3, 4, 6 and 24 hours after instillation)
• Time from maximum concentration to steady state (Tmax,ss) of PF-07225570 after multiple doses(Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 2 hours after instillation)
• Overall survival(Baseline up to 3 years)
• Incidence and titers of anti-drug antibodies (ADA) against sasanlimab(Pre-dose (within 6 hours) before each administration)