This trial is a phase I/II study, which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors.
This trial is a phase I/II study , which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors. Approximately 244-486 subjects with advanced malignant tumors will be enrolled. The study was divided into two phases: Phase I (Part A single therapy dose escalation and Part B combination therapy dose escalation) and Phase II (Part A single therapy dose expansion and Part B combination therapy dose expansion) .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
initial dose-MTD
provide medicine base on needs
Fujian Cancer Hospital
Fuzhou, Fujian, China
Union hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
safety and tolerability
To evaluate the safety, tolerability of LBL-019 monotherapy or combined with anti-PD-1 antibody, which is according to the number of DLT and the number of treatment related AES
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
Cmax
Maximum serum concentration
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
immunogenicity
The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects;
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
Pharmacodynamics
Receptor occupancy
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
ORR
Objective Response Rate
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
DCR
Disease Control Rate
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
DOR
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The first affiliated hospital with Nanjing medical university
Nanjing, Jiangsu, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
To measure duration of response
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months