Status:
RECRUITING
Evaluation of LBL-019 Monotherapy or Combined With Anti-PD-1 Antibody in the Treatment of Advanced Malignant Tumors
Lead Sponsor:
Nanjing Leads Biolabs Co.,Ltd
Conditions:
Advanced Malignant Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This trial is a phase I/II study, which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy...
Detailed Description
This trial is a phase I/II study , which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherap...
Eligibility Criteria
Inclusion
- Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;
- 18-75 years old (including boundary value), no gender limit;
- 3\. previous standard treatment failed, no standard treatment or standard treatment is not applicable at this stage;
- The expected survival time is at least 12 weeks;
Exclusion
- Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before using the study drug for the first time；
- Received any other investigational drug or treatment that is not on the market within 4 weeks prior to the initial use of the investigational drug;
- Women who are pregnant or breastfeeding;
- The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study
Key Trial Info
Start Date :
February 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 22 2025
Estimated Enrollment :
486 Patients enrolled
Trial Details
Trial ID
NCT05223231
Start Date
February 24 2022
End Date
October 22 2025
Last Update
May 7 2025
Active Locations (6)
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1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350000
2
Union hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
3
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
4
Hunan Cancer Hospital
Changsha, Hunan, China, 410006