Immunotherapy for urothelial carcinoma
A technology for urothelial carcinoma and PD-1, applied in the direction of anti-animal/human immunoglobulin, immunoglobulin, chemical instruments and methods, etc., can solve the problem of preferential depletion of CD8+TIL and reduction of anti-PD-1 tumor activity To achieve the effect of alleviating urothelial carcinoma and delaying the progression
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[0098] Study Design - Patient Identification and Recruitment
[0099] The purpose of this study design is to recruit UC patients for dose determination and initial patient identification, which will be carried out in phase 1A and 1B, respectively. The design of this study is detailed in figure 2 middle. exist figure 2 , * shows the dose expansion regimen; while A fixed dose representing an exposure not exceeding the maximum tolerated dose, and Indicates that it will proceed in parallel with Phase 1B.
[0100] Phase 1A is used to determine the safety, RP2D and preliminary efficacy of Mab-1. In Phase 1A, 10mg / kg every two weeks (once every 2weeks, Q2W) was the maximum administered dose of Mab-1, and the maximum tolerated dose (MTD) was not reached. In Part 1 of Phase 1A, a dose escalation study starting at 0.5 mg / kg Q2W to 10 mg / kg Q2W was conducted. In Part 2 of Phase 1A, a protocol extension study was conducted with Mab-1 Q2W or Q3W at 2 mg / kg or 5 mg / kg. A fixed...
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