Advanced Malignant Tumors
Conditions
Brief summary
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.
Detailed 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) .
Interventions
DRUGLBL-019 Injection
initial dose-MTD
DRUGanti-PD-1 antibody injection
provide medicine base on needs
Sponsors
Nanjing Leads Biolabs Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 time； 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety and tolerability | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months | Maximum serum concentration |
| immunogenicity | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months | The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects; |
| Pharmacodynamics | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months | Receptor occupancy |
| ORR | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months | Objective Response Rate |
| DCR | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months | Disease Control Rate |
| DOR | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months | To measure duration of response |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORcaicun zhou
Shanghai Pulmonary Hospital, Shanghai, China
Outcome results
None listed