Phase I/II Clinical Trial of LBL-015 for Injection

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

Detailed Description
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This trial is a single-arm, open, multi-center, dose-escalation and extended phase I/II study, aiming to evaluate the safety, tolerability, pharmacokinetic characteristics, and receptor occupancy of LBL-015 in patients with advanced malignant tumors Rate (RO), immunogenicity and effectiveness. Approximately 202 subjects with advanced malignant tumors are planned to be included. The study is divided into two phases: Phase I (dose escalation/PK expansion phase) and Phase II (indication expansion phase)

Official Title
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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

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: LBL-015 for Injections


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Agree to follow the trial treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form; Age ≥18 and ≤75 years old at the time of signing the informed consent form, regardless of gender; Eastern Cooperative Oncology Group performance status scoring criteria (ECOG) PS of 0   1 points (see Appendix 1 for criteria); Exclusion Criteria: 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: Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time; 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; 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; Use of immunomodulatory drugs within 14 days before the first use of study drugs, including but not limited to thymosin, interleukin-2, interferon, etc.;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evaluation of LBL-015 Phase I/II study in patients with advanced malignancies<br>Drug: LBL-015 for Injection The test drugLBL-003will be preset with 5 escalation dose levels: dose A , dose B, dose C ,dose D and dose E, administered twice a week. | Drug: LBL-015 for Injections<br>* LBL-015 was given every two weeks for treatment<br>* Other names: LBL-015;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose (MTD) | During the dose-escalation phase, the highest dose of dose-limiting toxicity for subjects less than or equal to 1/6 of the study drug within 4 weeks of starting treatment | 28 days after the first dose | 
| Dose-limiting toxicities（DLT) | During the DLT observation period, the subject has an event that is reasonably related to the test drug (possibly, likely or definitely related) | 28 days after the first dose |