A Multicenter, Open Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of LBL-033 in the Treatment of Patients With Advanced Malignant Tumors.
Overview
- Phase
- Phase 1
- Intervention
- LBL-033 for Injection
- Conditions
- Advanced Malignant Tumors
- Sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Enrollment
- 468
- Locations
- 6
- Primary Endpoint
- Dose-limiting toxicities（DLT）
- Status
- Recruiting
- Last Updated
- 12 months ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
LBL-033
LBL-033 for Injection; Initial dose - MTD; Q2W
Intervention: LBL-033 for Injection
Outcomes
Primary Outcomes
Dose-limiting toxicities（DLT）
Time Frame: 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)
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
- 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.)
- 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)
- 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)