Introduction
tumor, cancer, PD, deaths, Cancer
TUMOR, METASTATIC CERVICAL CANCER, CANCER, SOLID TUMORS, MICROSATELLITE INSTABILITY, SECONDARY, IMMUNE TOLERANCE, CANCER
According to the latest statistics from The Global Cancer Observatory (GLOBOCAN), there were an estimated 19.3 million new cases of cancer and nearly 10 million deaths worldwide in 2020, and 90% of cancer is solid tumors (The PD-1/PD-L1–based pathway is of great value in tumor immunotherapy. It is a critical immune checkpoint that controls the induction and maintenance of immune tolerance in the tumor microenvironment. Blocking the binding of PD-1/PD-L1 with an immune checkpoint inhibitor allows the T-lymphocytes to kill tumor cells (QL1604 is a highly selective, humanized immunoglobulin G4 monoclonal antibody (mAb) against PD-1 immune checkpoint signaling. QL1604 remains an investigational drug with at least three clinical trials in solid tumors, including QL1604 monotherapy for unresectable or metastatic mismatch repair–deficient or high–microsatellite instability solid tumors (NCT04326829), and QL1604 plus chemotherapy versus chemotherapy in patients with stage IVB, recurrent, or metastatic cervical cancer (NCT04864782) (Here, we report the results of a first-in-human, open-label, phase I study of QL1604 in patients with advanced or metastatic solid tumors. The primary objective of this study was to observe the safety and tolerability of single and multiple dosing of QL1604 and to determine the recommended doses for future clinical studies. The secondary objectives were to characterize the pharmacokinetics (PK)/pharmacodynamics (PD) and immunogenicity and to evaluate the preliminary antitumor activity of QL1604.