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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
468
Initial dose - MTD; Q2W; intravenous infusion
Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
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.
Time frame: 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
Time frame: At the end of Cycle 1(28 days after the first prespecified dose)
Cmax
Maximum serum concentration
Time frame: 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
After taking a single dose, Time to reach maximum plasma concentration
Time frame: 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
Time frame: 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).
Time frame: 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
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Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
RECRUITINGObstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGWest China Second University Hospital,Sichuan University
Chengdu, Sichuan, China
RECRUITINGDuration of Response(DOR)
The period from the participants first achieving CR or PR to disease progression.
Time frame: 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
Time frame: 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.