Locally advanced or metastatic solid tumors
Conditions
Interventions
Experimental group:LAT010 combined with pembrolizumab
Sponsors
Shanxi Bethune Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The patient is able to understand the informed consent form, voluntarily participates and signs the informed consent form. 2. The patient has the ability and willingness to comply with the visit, treatment plan, laboratory tests and other research-related procedures as stipulated in the research protocol. 3. The age at signing the informed consent form is 18 to 80 years old, and gender is not restricted. 4. For patients with locally advanced or metastatic solid tumors (if it is non-squamous non-small cell lung cancer, it must be confirmed that there are no EGFR/ALK/ROS1 sensitive mutations), and meeting one of the following conditions: progression after standard treatment; inability to tolerate standard treatment; inability to obtain standard treatment for various reasons; according to the Eastern Cooperative Oncology Group (ECOG) scoring criteria, the performance status score is 0 or 1. 5. The patient's expected survival period is >= 12 weeks as evaluated by the investigator. 6. The investigator assesses that the patient's expected survival period is >= 12 weeks. 7. According to the RECIST 1.1 assessment criteria, the patient has at least one measurable lesion, and a measurable lesion is defined as a non-lymph node lesion that can be measured with a CT or MRI imaging with a longest diameter >= 10 mm or a single pathological lymph node lesion with a short diameter >= 15 mm. If the lesion that received local treatment (radiation therapy, ablation, vascular intervention, etc.) is the only lesion, there must be clear imaging evidence of disease progression after local treatment. 8. The main organ functions meet the following standards within 7 days before the first administration, including no component blood transfusion, human granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), thrombopoietin receptor agonist, interleukin-11 and erythropoietin (EPO) support therapy within 7 days before the test: a. Hematology i. Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; ii. Platelet count (PLT) >= 100 × 10^9 cells/L; iii. Hemoglobin (HGB) >= 90 g/L. b. Kidney i. Creatinine clearance rate calculated according to the Cockcroft-Gault formula >= 60 mL/min. c. Coagulation i. International normalized ratio (INR) = 90 days after the last administration (excluding grade 2 AE that cannot be restored to <= grade 1 and remains stable for a long time). Women of childbearing age and those < 12 months
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to any component of the test drug formulation, IL-2, or anti-PD-1/PD-L1 antibodies, or have permanently discontinued the drug due to drug-related adverse events (AEs) caused by pembrolizumab or similar drugs in the past, or have permanently discontinued the drug due to drug-related AEs caused by IL-2 or similar drugs in the past. 2. Patients have a history of severe immune-related adverse events (irAEs) from previous treatments, defined as grade 4 adverse events requiring corticosteroid treatment or grade 3 adverse events requiring corticosteroid hormone treatment > 10 mg/day or equivalent dose of prednisone treatment > 12 weeks. 3. Severe or uncontrolled cardiovascular diseases that require treatment, including but not limited to: a. New York Heart Association (NYHA) cardiac function classification > 1 grade, or left ventricular ejection fraction (LVEF) 470 msec; g. Drug-uncontrolled epilepsy; h. History of stroke, cerebrovascular accident, or transient ischemic attack within 6 months of first administration. 4. Known to have chronic obstructive pulmonary disease (COPD) and forced expiratory volume in one second (FEV1) of 30% or less of the predicted normal value. It should be noted that patients suspected of having COPD must undergo FEV1 testing, and if FEV1 is 30% or less of the predicted normal value, exclusion is required. 5. Known to have moderate or severe persistent asthma, or a history of asthma in the past 2 years, or any uncontrolled asthma of any classification (note that intermittent asthma or mild persistent asthma with controlled current condition is allowed to participate in the study). 6. History and current presence of interstitial pneumonia (including drug-induced), radiation pneumonitis, pneumoconiosis, pulmonary fibrosis, or severely impaired lung function; active tuberculosis, undergoing anti-tuberculosis treatment or having received anti-tuberculosis treatment within 1 year before first administration. 7. Participated in any therapeutic clinical study within 28 days before the first administration and was enrolled for treatment, unless in an observational study or the survival follow-up stage of an intervention study. 8. Received any IL-2-related treatment within 6 months before the first administration; used immunomodulatory drugs within 14 days or 5 half-lives (whichever is longer) before the first administration, including but not limited to thymosin, IL-15, interferon, etc. 9. Received chimeric antigen receptor T-cell immunotherapy (CAR-T) or chemotherapy within 120 days before the first administration; received endocrine therapy, targeted therapy (with a washout period of 14 days or 5 half-lives for small molecule targeted therapy, whichever is longer), immunotherapy (immunomodulatory drugs see exclusion criteria 7), tumor embolization, etc. within 28 days before the first administration; received radiotherapy within 14 days before the first administration, palliative radiotherapy for symptom control is allo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events during treatment (TEAE);The incidence and toxicological characteristics of dose-limiting toxicity (DLT);The clinical test results of safety, vital signs, and 12-lead electrocardiogram (ECG), as well as the changes between them and the corresponding baseline;The incidence rate of serious adverse events (SAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);The non-atrial and ventricular pharmacokinetic parameters of LAT010;Disease Control Rate (DCR);Relief time (DOR); | — |
Countries
China
Contacts
Public ContactFeng Huijing
Shanxi Bethune Hospital
Outcome results
None listed