A Phase Ib/II Clinical Trial Evaluating the Safety and Efficacy of TQB6411 Injection in Subjects With Recurrent or Metastatic Esophageal Cancer Who Have Failed Prior PD-1/PD-L1 Inhibitor Plus Platinum-Based Chemotherapy
The Phase Ib stage of this study primarily aims to evaluate the tolerance and safety of TQB6411 Injection in subjects with recurrent or metastatic Esophageal cancer who have previously failed treatment with PD-1/PD-L1 monoclonal antibodies combined with platinum-based chemotherapy. The Phase II stage primarily aims to evaluate the efficacy of TQB6411 Injection in this same patient population.
• Subjects voluntarily participate in this study, sign the informed consent form, and demonstrate good compliance.
• Age between 18 and 75 years old (inclusive)
• Eastern Cooperative Oncology Group (ECOG) score of 0-1
• Expected survival \>12 weeks
• At least one measurable lesion per RECIST v1.1
• Laboratory criteria(no hematopoietic growth factor correction within 7 days)：
‣ Hemoglobin (HGB) ≥90 g/L;
⁃ Absolute neutrophil count (NEUT) ≥1.5×10⁹/L;
⁃ Platelets (PLT) ≥90×10⁹/L;
⁃ Total bilirubin (TBIL) ≤1.5×ULN;
⁃ Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×ULN (≤5×ULN if liver metastases present);
⁃ Serum creatinine (CR) ≤1.3×ULNorcreatinine clearance rate (CCR) ≥50 mL/min;
• Histologically/cytologically confirmed recurrent or metastatic Esophageal cancer
• Failure/intolerance to prior PD-1/PD-L1 inhibitor plus platinum-based chemotherapy for recurrent/metastatic Esophageal Carcinoma (EC)
• Willingness to provide archived or fresh tumor tissue for biomarker analysis.
• Females of childbearing potential: Negative serum/urine pregnancy test within 7 days before enrollment and agreement to use effective contraception during and for 6 months post-study. Males: Agreement to use effective contraception during and for 6 months post-study.