This is an open-label, dose escalation, first-in-human study of HLX20, an anti-PD-L1
monoclonal antibody, in patients with metastatic or recurrent solid tumors who have failed
Tumor microenvironment plays an important role in the interaction of immune cells with cancer
. The identification of programmed cell death receptor 1 (PD-1) and programmed death ligand-1
(PD-L1) have provided the scientific rationale and supports the clinical development of
agents targeting this pathway. Currently, PD-1 and PD-L1 inhibitory pathway blockade has
demonstrated impressive activity against a spectrum of multiple tumor types, including
Hodgkin's lymphoma, melanoma, bladder cancer, lung cancer, renal cell carcinoma.
HLX20 is a novel anti-PD-L1 monoclonal antibody. In the nonclinical pharmacology studies,
HLX20 has demonstrated anti-tumor activities in xenogenic animal models comparable to
currently available anti-PD-L1 monoclonal antibodies. HLX20 binds to PD-1 and PD-L1
inhibitory pathway and human PD-L1 at high affinity, and mouse PD-L1 at much lower affinity.
HLX20 does not cause hemolysis to human red blood cells and has no local irritation to human
tissues. (The results of pharmacokinetic (PK)/toxicokinetic studies in cynomolgus studies
have been described in detail in the Investigator's Brochure.)The no-observable adverse
effect level (NOAEL) is set at 100 mg/kg every 2 weeks for 13 weeks in cynomolgus studies.
Based on these results, the initial dose 1 mg/kg every 2 weeks was chosen for this study
.This dose level is approximately 30-fold lower than the human equivalent dose of NOAEL from
preclinical toxicology studies. An adaptive Bayesian dose-finding design will be used to
identify the MTD (maximum tolerated dose). The target toxicity rate for the MTD is set at 0.3
and the maximum sample size is 30.The safety profiles at different dose levels, PK
parameters, biomarkers, pharmacodynamic markers, immunogenicity as well as the preliminary
efficacy of the drug, will also be investigated in this study.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.