Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT03588650
Brief Summary:
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 standard therapy.
Detailed Description:
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.
Study:
NCT03588650
Study Brief:
Protocol Section:
NCT03588650