A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors
About the study
This trial is an open and multicenter phase Ib/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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 and ≤ 75 years old when signing the informed consent form, regardless of gender;
- The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) PS is 0~1;
- The expected survival time is at least 12 weeks;
- According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), the subjects enrolled have at least one measurable tumor lesion;
- Subject has adequate organ and bone marrow function
- 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
Exclusion Criteria:
- Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
- Those who have clinically uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage or medical intervention;
- 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.
- Patients with history of severe cardiovascular and cerebrovascular diseases.
- Patients with active infection and currently requiring intravenous anti-infective treatment
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Malignant Tumors
Age
18+
Phase
PHASE1/PHASE2
Participants Needed
490
Est. Completion Date
Jun 30, 2025
Treatment Type
INTERVENTIONAL
Sponsor
Nanjing Leads Biolabs Co.,Ltd
ClinicalTrials.gov NCT Identifier
NCT05516914
Study Number
LBL-007-CN-004
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