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This trial is an open and multicenter phase I/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
This is an open, multicenter Phase I/II clinical trial of LBL-033 in the treatment of patients with advanced malignant tumors,which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
The trial is divided into 2 parts: Phase 1 and Phase 2
Phase I study:
Dose-escalation and PK expansion.The PK expansion study will be judged on the basis of dose escalation data.
Phase II study:
Dose expansion included 4 cohorts that required patients with MUC16-positive malignancies.Blood samples will be collected from all subjects in this trial.
Phase I and Phase II studies are expected to recruit 113-468 patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBL-033 | Experimental | LBL-033 for Injection; Initial dose - MTD; Q2W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBL-033 for Injection | Drug | Initial dose - MTD; Q2W; intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities(DLT) | DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. | At the end of Cycle 1(28 days after the first prespecified dose) |
| Maximum tolerated dose (MTD) | MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycles | At the end of Cycle 1(28 days after the first prespecified dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum serum concentration | From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy |
| Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jihong liu | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China | ||
| Sun Yat-sen University Cancer Center |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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After taking a single dose, Time to reach maximum plasma concentration
| From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy |
| immunogenicity | The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects | From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy |
| Disease Control Rate(DCR) | Percentage of participants achieving CR and PR and stable disease (SD). | From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy |
| Duration of Response(DOR) | The period from the participants first achieving CR or PR to disease progression. | From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy |
| Objective Response Rate (ORR) | Objective Response Rate (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), refers to the percentage of study subjects who achieve a complete response or partial response. This Secondary Outcome Measure was used for efficacy observations in Phase I study | From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy. |
| Guangzhou |
| Guangdong |
| 510062 |
| China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450003 | China |
| Liaoning Cancer Hospital & Institute | Shenyang | Liaoning | 110801 | China |
| Obstetrics & Gynecology Hospital of Fudan University | Shanghai | Shanghai Municipality | 200011 | China |
| West China Second University Hospital,Sichuan University | Chengdu | Sichuan | 610044 | China |