A Phase I/II Clinical Trial of LBL-033 in the Treatment of Advanced Malignant Tumors
- Conditions
- Advanced Malignant Tumors
- Interventions
- Drug: LBL-033 for Injection
- Registration Number
- NCT05779163
- Lead Sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Brief Summary
This trial is an open and multicenter phase I/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 468
- Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form;
- Age ≥ 18 years old when signing the informed consent form;
- The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1;
- The expected survival time is at least 12 weeks;
- According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable Target lesion;
- Subject has adequate organ and bone marrow function，Conforming to laboratory test results:
- Males with fertility and females of childbearing age are willing to take effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets，etc）; Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.
- Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
- Patients with active infection and currently requiring intravenous anti-infective treatment；
- Those who have clinically uncontrollable pleural effusion, pericardial effusion , requiring repeated drainage or medical intervention;
- The patient has a Medical history of immunodeficiency, including HIV antibody positive；
- Women during pregnancy or lactation;
- The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LBL-033 LBL-033 for Injection LBL-033 for Injection; Initial dose - MTD; Q2W
- Primary Outcome Measures
Name Time Method Dose-limiting toxicities（DLT） At the end of Cycle 1（28 days after the first prespecified dose） 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.
Maximum tolerated dose (MTD) At the end of Cycle 1（28 days after the first prespecified dose） 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
- Secondary Outcome Measures
Name Time Method Cmax 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 Maximum serum concentration
immunogenicity 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 The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects
Duration of Response(DOR） 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 The period from the participants first achieving CR or PR to disease progression.
Objective Response Rate (ORR) 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 (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
Tmax 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 After taking a single dose, Time to reach maximum plasma concentration
Disease Control Rate(DCR） 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 Percentage of participants achieving CR and PR and stable disease (SD).
Trial Locations
- Locations (6)
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Obstetrics & Gynecology Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
West China Second University Hospital,Sichuan University
🇨🇳Chengdu, Sichuan, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China