Overview
This trial is an open and multicenter phase I/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
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
Eligibility
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.