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Quavonlimab (MK-1308) is a new anti-CTLA-4 antibody.
study aims to assess the safety and efficacy of Quavonlimab and Pembrolizumab (face party class) for advanced metastasis solid tumors.
the study is a Phase I clinical trial, divided into two phases.
In the dose increment (DE) phase: patients with advanced/metastasis solid tumors receive an initial flat dose of Quaponlimab as a single treatment of 25 mg (queue 1), 75 mg (queue 2) or 200 mg (queue 3), followed by a total of 4 courses of treatment at the same dose of Quavonlimab-Pim monoantigen (Q3W).
at dose verification (DC) stage: patients with stage IIIB/IV non-small cell lung cancer (NSCLC) receive first-line Quvonlimab (25 mg Q3W (Group A), 25 mg Q6W (Group B), 75 mg Q6W (Group C) or 75 mg Q3W (Group E) .
the main objectives are safety and tolerance, as well as determining the recommended phase 2 dose (RP2D) when used in union with Pim monoant.
objective response rate (ORR) is the secondary endpoint.
efficacy based on PD-L1 expression, tumor mutation load (TMB) and circulating CD4-/CD8-plus cell changes is an exploratory endpoint.
recruited 39 patients in the DE phase: 14, 17 and 8 in queues 1, 2 and 3, and 134 patients in the DC phase: 40 in groups A, B, C and E, respectively.
40th and 14th.
did not reach the maximum to-dosage.
3 to 5 treatment-related adverse events (AEs) in stages 1, 2 and 3 of the DE phase were 0%, 23.5% and 75.0%, respectively, and the AE rates in stages A, B, C and E were 35.0%, 30.0%, 35.0% and 57.1%, respectively.
all dose levels/programmes were observed to be effective in NSCLC patients.
orR values for Groups A, B, C and E were 40.0%, 37.5%, 27.5% and 35.7%, respectively.
total number of PD-L1 expression and circulating CD4 plus cells was associated with ORR.
addition, of all Quavonlimab doses/programmes evaluated in this study, Quavonlimab 25mg Q6W combined Pym monoantigen showed similar efficacy and better safety, and chose this option as RP2D.
