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

• Status: Not yet recruiting
• Trial end date: 2026-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing Leads Biolabs Co.,Ltd

Criteria

Inclusion Criteria:

1. Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form;

2. Age ≥ 18 years old when signing the informed consent form;

3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1;

4. The expected survival time is at least 12 weeks;

5. According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable Target lesion;

6. Subject has adequate organ and bone marrow function，Conforming to laboratory test results:

7. 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:

1. Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;

2. Patients with active infection and currently requiring intravenous anti-infective treatment；

3. Those who have clinically uncontrollable pleural effusion, pericardial effusion , requiring repeated drainage or medical intervention;

4. The patient has a Medical history of immunodeficiency, including HIV antibody positive；

5. Women during pregnancy or lactation;

6. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.