Clinical Trial of TQB2618 Injection Combined With TQB2450 Injection in Patients With Advanced Solid Tumors

Inclusion Criteria:

• The subjects voluntarily participated the study and signed the informed consent form;
• Age: 1875 years old (when signing the informed consent form); ECOG PS score: 01points; Expected survival is more than 3 months;
• The enrolled patients meet the following criteria:

1. Satge I (dose exploration): patients with advanced malignant solid tumorsconfirmed by tissue and/or cytology, where standard therapy has failed or thereis a lack of effective treatment;
2. Stage 2 (cohort Expansion):
3. Cohort 1: PD-L1-positive patients with advanced first-line NSCLC;
4. Cohort 2: PD-L1 positive patients with advanced immunoresistant NSCLC;
5. Patients with locally advanced (stage III.B/III.C), recurrent ormetastatic (stage IV) NSCLC who are not histologically or cytologicallyconfirmed and are not suitable for radical concurrentchemoradiotherapy.
6. For non-squamous non-small cell lung cancer, the test proves theabsence of EGFR mutation, ALK fusion, ROS1 mutation (for squamousnon-small cell lung cancer, patients with known mutations in the abovegenes are excluded, and testing is not mandatory for those whose statusis unknown);
7. Positive PD-L1 expression ratio≥1% [TC (tumor cells) or IC (immunecells) ≥1%];
8. Cohort 1 advanced first-line patients: no systemic antitumor therapyfor advanced disease.
9. Patients with advanced immunoresistance in cohort 2: at least priorfailure of platinum-containing chemotherapy and immune checkpointinhibitor (PD-1 or PD-L1) therapy (combined or sequential therapyallowed)

• at least one measurable lesion confirmed according to RECIST 1.1;
• The main organs function normally
• Female subjects of childbearing age should agree that contraception must be usedduring the study and for 6 months after the end of the study

Exclusion Criteria:

• Comorbidities and medical history:

1. Have received chemotherapy within 3 weeks before the first dose, radiotherapy (except palliative radiotherapy for non-target lesions) or other antineoplasticdrugs within 2 weeks before the first dose (the washout period is calculated fromthe end of the last treatment);
2. Have developed or are currently suffering from other malignant tumors within 3years before the first dose. The following two conditions can be enrolled: othermalignancies treated with a single surgery, achieving 5 consecutive years ofdisease-free survival (DFS); cured carcinoma in situ, non-melanoma skin cancer,and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ),and T1 (tumor-invasive basement membrane)];
3. unresolved toxicities above CTC AE grade 1 due to any prior treatment, excludinghair loss;
4. Major surgical treatment and obvious traumatic injury within 28 days before thefirst dose;
5. Wounds or fractures that have not healed for a long time;
6. Arterioven/venous thrombotic events within 6 months prior to the first dose;
7. Those with a history of psychotropic substance abuse and cannot quit or havemental disorders;
8. Subjects with any severe and/or uncontrolled disease.

• Tumor-related symptoms and treatment:

1. Received proprietary Chinese medicine treatment with anti-tumor indicationsspecified in the NMPA-approved drug instructions within 2 weeks before the firstdose;
2. Have received previous anti-TIM-3 antibody treatment;
3. Have received previous immunotherapy drugs such as anti-PD-1/PD-L1 antibody andanti-CTLA-4 antibody (only applicable to cohort 1 of the Stage II cohortexpansion study: advanced first-line NSCLC patients with positive PD-L1expression);
4. uncontrolled pleural effusion, pericardial effusion, or ascites that stillrequires repeated drainage (judged by the investigator);
5. Known spinal cord compression, cancerous meningitis, with symptoms of brainmetastases or symptom control for less than 2 weeks;

• Study treatment-related:

1. History of live attenuated vaccination within 28 days before the first dose orplanned live attenuated vaccination during the study period;
2. Those who have severe hypersensitivity reactions after using macromoleculardrugs;
3. Active autoimmune disease requiring systemic therapy within 2 years before thefirst dose (e.g., use of disease-modifying drugs, corticosteroids, orimmunosuppressants); asthma patients requiring bronchodilators for medicalintervention.

• Those who have participated in and used other anti-tumor clinical trial drugs within 4weeks before the first dose;