Overview

Phase Ib/II Clinical Study of LBL-007 in Treatment of Advanced Malignant Tumors

Status:
Not yet recruiting
Trial end date:
2023-07-14
Target enrollment:
0
Participant gender:
All
Summary
This trial is a single-arm, open, multi-center phase Ib/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 and ≤ 75 years old when signing the informed consent form, regardless of
gender;

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

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

5. Males with fertility and females of childbearing age are willing to take effective
contraceptive measures (including abstinence, intrauterine device, various hormonal
contraception, correct use of contraception from the signing of the informed consent
form to 6 months after the last administration of the trial drug) 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. Those who have used anti-LAG-3 antibody immunotherapy in the past;

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

4. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell
transplantation, except for those who do not need to use immunosuppressive agents
(such as corneal transplantation);

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.