A Clinical Trial on the Efficacy and Safety of TQB6411 for Injection

Exclusion Criteria36

• History of or concurrent other malignancies, except for: other malignancies treated with surgery alone and achieving ≥5 years of disease-free survival (DFS); or cured carcinoma in situ of cervix, non-melanoma skin cancer, or superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading basement membrane)\].
• Diseases affecting intravenous injection or blood sampling.
• Adverse reactions from prior therapies not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v6.0 grade ≤1, except for: grade 2 alopecia, grade 2 peripheral neuropathy, grade 2 anemia, non-clinically significant asymptomatic grade 2 laboratory abnormalities, hypothyroidism stabilized with hormone replacement, or other toxicities judged by investigator as non-safety risks.
• Major surgery (Grade 3 or above per National Surgical Classification Catalog 2022), significant traumatic injury within 4 weeks prior to first dose, planned major surgery during study (except protocol-specified procedures), or presence of unhealed wounds/fractures.
• Any bleeding or hemorrhagic events ≥CTCAE grade 3 within 4 weeks prior to first dose.
• Arterial/venous thromboembolic events within 6 months prior to first dose, including: cerebrovascular accidents (including transient ischemic attack (TIA), excluding lacunar infarction), deep vein thrombosis, or pulmonary embolism (implantable venous port- or catheter-related thrombosis or superficial venous thrombosis not considered "severe" thromboembolism).
• Active viral hepatitis with poor control, except: hepatitis B surface antigen (HBsAg)-positive subjects with Hepatitis B virus Deoxyribonucleic acid (HBV DNA) <500 IU/mL (2500 copies/mL) who agree to receive anti-HBV therapy throughout study; or hepatitis C virus (HCV)-infected subjects (Hepatitis C Virus Antibody or Ribonucleic Acid positive) with hepatitis C virus Ribonucleic Acid (HCV RNA) ≤ULN continuing approved antiviral therapy.
• Active syphilis requiring treatment.
• Active tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced/radiation pneumonitis requiring treatment, clinically significant active pneumonia, history of interstitial lung disease (ILD) requiring treatment, or current ILD.
• History of psychotropic drug abuse or mental disorders.
• Prior or planned allogeneic bone marrow or solid organ transplantation.
• History of hepatic encephalopathy.
• Significant cardiovascular diseases including:
• Cardiac dysfunction ≥New York Heart Association (NYHA) class II or Left Ventricular Ejection Fractions (LVEF) <50% by echocardiography;
• Clinically significant ventricular arrhythmia history (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or arrhythmias requiring continuous antiarrhythmic therapy (subjects with stable atrial fibrillation controlled solely by β-blockers may be included after investigator assessment);
• Unstable angina;
• Myocardial infarction within 12 months;
• Cardio contraction time (QTc) >450ms (male) or >470ms (female) (if abnormal, measure three times at ≥2-minute intervals and average; corrected by Fridericia or Bazett method);
• Congenital long QT syndrome or family history.
• Active or uncontrolled severe infection (≥CTCAE grade 2).
• Renal failure requiring hemodialysis or peritoneal dialysis.
• Immunodeficiency including HIV positivity or other acquired/congenital immunodeficiency diseases.
• Uncontrolled autoimmune diseases requiring immunosuppressants or systemic corticosteroids (>10mg prednisone/day equivalent) within 7 days prior to first dose.
• Epilepsy requiring treatment.
• Poorly controlled diabetes (fasting blood glucose >10mmol/L).
• Tumor-related conditions and treatments:
• Chemotherapy, immunotherapy, or small-molecule targeted therapy within 3 weeks prior to first dose or within 5 half-lives (whichever shorter); prior local radiotherapy allowed if: completed >4 weeks (>2 weeks for brain) before study treatment, and target lesions are outside radiation field or show progression within field;
• National Medical Products Administration (NMPA)-approved traditional Chinese medicines with antitumor indications within 1 week prior to first dose;
• Tumor invading major vessels or judged likely to cause fatal hemorrhage;
• Uncontrolled effusions/ascites requiring recurrent drainage;
• Spinal cord compression, leptomeningeal metastases, or brain metastases with symptoms controlled <4 weeks, or requiring steroids/dehydrating agents within 2 weeks before treatment.
• Known hypersensitivity to study drug or excipients.
• Prior treatment with: Epidermal Growth Factor Receptor/cellular-mesenchymal epithelial transition factor (EGFR/c-Met)-targeted antibody-drug conjugates (ADCs); or topoisomerase I inhibitors (Non-Small Cell Lung Cancer only) or topoisomerase I inhibitor-based ADCs.
• Prior EGFR/c-Met-targeted Monoclonal Antibody (mAbs)/bispecifics with: ≥grade 4 toxicity, permanent discontinuation due to toxicity, ≥grade 3 infusion reactions, or ≥grade 3 myalgia.
• Participation in other antitumor clinical trials within 4 weeks prior to first dose.
• Other conditions judged by investigator to jeopardize subject safety or study completion.