An Open-label, Multi-center, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti Tumor Activity of LBL-015 in Patients With Advanced Malignant Tumors

LBL-015-CN-001

A phase I/II clinical study evaluating LBL-015 in the treatment of subjects with advanced solid tumors

2021-11-05

2024-10-01

2024-12-01

Recruiting

Early phase I

202

Inclusion Criteria: 1. Agree to follow the trial treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form; 2. Age ≥18 and ≤75 years old at the time of signing the informed consent form, regardless of gender; 3. Eastern Cooperative Oncology Group performance status scoring criteria (ECOG) PS of 0 \~ 1 points (see Appendix 1 for criteria); 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, except for the following items: 2. Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time; 3. Patients who have previously received treatment with PD-1/PD-L1 and TGF-β bifunctional antibody drugs or received treatment with PD-1/PD-L1 combined with TGF-β target drugs; 4. Patients who have undergone major organ surgery (excluding needle biopsy) or have significant trauma within 4 weeks before using the study drug for the first time,or required elective surgery during the trial period; 5. Use of immunomodulatory drugs within 14 days before the first use of study drugs, including but not limited to thymosin, interleukin-2, interferon, etc.;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 202, 'type': 'ESTIMATED'}}

2024-01-24