Clinical trial
A Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LBL-007 in Combination With Toripalimab in the Treatment of Advanced Malignancies
Name
LBL-007-CN-003
Description
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.
Trial arms
Trial start
2021-11-30
Estimated PCD
2024-07-01
Trial end
2024-12-14
Status
Recruiting
Phase
Early phase I
Treatment
LBL-007 Injection
LBL-007 Injection; dose A or dose B; Q3W
Arms:
LBL-007&Toripalimab
Other names:
LBL-007
Toripalimab Injection
Toripalimab is infused with a fixed dose of 3 mg/kg intravenously every three weeks
Arms:
LBL-007&Toripalimab
Size
200
Primary endpoint
Objective Response Rate (ORR)
All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy)
Dose-limiting toxicities（DLT）
During the first Cycles(each cycle is 21 days)
Maximum tolerated dose (MTD)
During the first Cycles(each cycle is 21 days)
Eligibility 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 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. 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2024-03-27
1 organization
2 products
1 indication
Product
LBL-007Indication
Advanced Solid TumorOrganization
Nanjing Leads BiolabsProduct
Toripalimab