RecruitingPhase 1Phase 2NCT05779163

A Phase I/II Clinical Trial of LBL-033 in the Treatment of Advanced Malignant Tumors

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.

Sponsor

Nanjing Leads Biolabs Co.,Ltd

Enrollment

468 participants

Start Date

Apr 14, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Malignant Tumors

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria6

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.