Overview
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.
Description
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) .
Eligibility
Inclusion Criteria:
1.Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign
the informed consent form;
2.18-75 years old (including boundary value), no gender limit;
3. previous standard treatment failed, no standard treatment or standard treatment is not
applicable at this stage;
4.The expected survival time is at least 12 weeks;
Exclusion Criteria:
1. Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy,
immunotherapy and other anti-tumor treatments within 4 weeks before using the study
drug for the first timeļ¼
2. Received any other investigational drug or treatment that is not on the market within
4 weeks prior to the initial use of the investigational drug;
3. Women who are pregnant or breastfeeding;
4. The investigator believes that the subject has other conditions that may affect
compliance or are not suitable for participating in the study