Clinical Trial Evaluating the Safety of the TQB2103 for Injection

Inclusion Criteria:

• Patients with advanced malignant tumours confirmed by histology or cytology, diseaseprogression or intolerance after adequate standard treatment, or lack of standardtreatment options, or standard treatment is not applicable currently .
• Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS)score: 0-1; The expected survival time is more than 3 months.
• Patients who can provide fresh-collected or stored tumour tissue samples within 2years for Claudin 18.2 expression level detection were preferentially enrolled, andthose who cannot provide samples during the dose-escalation stage were also eligibleto participate in the study; In the dose-expansion stage, subjects who could notprovide tumour tissue samples for Claudin 18.2 expression level detection needed to bediscussed with the investigators on a case-by-case basis, and enrollment may beallowed according to the specific situation.
• At least one evaluable tumour lesion according to Response Evaluation Criteria InSolid Tumors (RECIST) v1.1 in the dose-escalation study and at least one measurablelesion in the dose-expansion study (the lesion that received radiotherapy can be usedas the target lesion after definite progression according to RECIST v1.1 evaluation).
• Good function of major organs.
• Fertile subjects should agree that contraception must be used during the study and for 6 months after the end of the study; Women of childbearing age had a negative serumpregnancy test within 7 days prior to study enrollment and had to be non-lactatingsubjects.
• Evidence of a personally signed and dated informed consent document indicating thatthe patient has been informed of all pertinent aspects of the study.

Exclusion Criteria:

• Comorbidities and medical history:

1. Have developed or are currently concurrent with other malignant tumors within thepast 5 years.
2. Have a high risk of Gastrointestinal (GI) bleeding, or have active severe GIdisease.
3. Patients with current interstitial lung disease or pulmonary fibrosis,pneumoconiosis, radiation pneumonitis, severe impairment of lung function, etc.,which may interfere with the detection and management of suspected drug-relatedpulmonary toxicity.
4. All reversible adverse events caused by any previous treatment have not recoveredto CTCAE 5.0 grade ≤ grade 1, before the first dose of the investigational drug.
5. Major surgical treatment, open biopsy, or significant traumatic injury within 4weeks before the start of study treatment; Elective surgery was required duringthe trial; Or have wounds, ulcers or fractures that have not healed for a longtime.
6. Occurrence of arterial/venous thrombosis events within 6 months, such ascerebrovascular accident, deep vein thrombosis, and pulmonary embolism; Peoplewho have a history of psychotropic drug abuse and cannot abstain from it or havemental disorders.
7. Subjects with any severe and/or uncontrolled illness.

• Cancer-related symptoms and treatment:

1. Received systemic antineoplastic therapy such as radical surgery, chemotherapy,radical radiotherapy or immunotherapy, biological therapy or participated inClinical trials of other interventional antineoplastic drugs within 4 weeksbefore the initiation of study treatment.
2. Prior therapy against the Claudin18.2 target, such as Claudin18.2 monoclonalantibodies, bispecific antibody, ADC, or chimeric antigen receptor T-cellimmunotherapy (CAR-T).
3. Tumour has invaded important blood vessels on imaging (Computed Tomography (CT)or Magnetic Resonance Imaging(MRI)) or judged by the investigator to be highlylikely to invade important blood vessels during the follow-up study.
4. Poorly controlled pleural, pericardial or peritoneal effusion requiring repeateddrainage, judged by the investigator to be unsuitable for enrollment.
5. Subjects with known active central nervous system metastases and/or meningealmetastases or spinal cord compression.

• Study treatment-related:

1. A history of vaccination with the live attenuated vaccine within 28 days beforeinitiation of study treatment or a planned vaccination with live attenuatedvaccine during the study.
2. The subject has a history of severe hypersensitivity after previous exposure to ahumanized monoclonal antibody or acute or delayed hypersensitivity or intoleranceto known components of TQB2103.
3. Requiring systemic therapy within 2 years before initiation of study treatment.

• Subjects with concomitant diseases that seriously endanger the safety of the subjectsor affect the completion of the study, or subjects who are considered to be unsuitablefor enrollment for other reasons, according to the judgment of the investigators.