Advanced Malignant Tumors Clinical Trial
Official title:
A Multicenter, Open Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LBL-019 Monotherapy or Combination Anti-PD-1 Antibody in Patients With Advanced Malignant Tumors
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 or combined with anti-PD-1 antibody in patients with advanced malignant tumors.
Status | Recruiting |
Enrollment | 486 |
Est. completion date | October 22, 2025 |
Est. primary completion date | March 22, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1.Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form; 2.18-75 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; 4.The expected survival time is at least 12 weeks; Exclusion Criteria: 1. 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; 2. 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; 3. Women who are pregnant or breastfeeding; 4. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study |
Country | Name | City | State |
---|---|---|---|
China | Hunan Cancer Hospital | Changsha | Hunan |
China | Fujian Cancer Hospital | Fuzhou | Fujian |
China | The first affiliated hospital with Nanjing medical university | Nanjing | Jiangsu |
China | Shanghai Pulmonary Hospital | Shanghai | Shanghai |
China | Hubei Cancer Hospital | Wuhan | Hubei |
China | Union hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Nanjing Leads Biolabs Co.,Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | safety and tolerability | To evaluate the safety, tolerability of LBL-019 monotherapy or combined with anti-PD-1 antibody, which is according to the number of DLT and the number of treatment related AES | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months | |
Secondary | Cmax | Maximum serum concentration | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months | |
Secondary | immunogenicity | The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects; | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months | |
Secondary | Pharmacodynamics | Receptor occupancy | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months | |
Secondary | ORR | Objective Response Rate | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months | |
Secondary | DCR | Disease Control Rate | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months | |
Secondary | DOR | To measure duration of response | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months |
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