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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) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBL-019 | Experimental | singal -arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBL-019 Injection | Drug | initial dose-MTD |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum serum concentration | 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; |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| caicun zhou | Shanghai Pulmonary Hospital, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Fuzhou | Fujian | 350000 | China | ||
| Union hospital Tongji Medical College Huazhong University of Science and Technology |
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| anti-PD-1 antibody injection | Drug | provide medicine base on needs |
|
|
| 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 | 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 | 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 | 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 | To measure duration of response | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months |
| Wuhan |
| Hubei |
| 430022 |
| China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410006 | China |
| The first affiliated hospital with Nanjing medical university | Nanjing | Jiangsu | 210000 | China |
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| ID | Term |
|---|---|
| C000711728 | spartalizumab |
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