Clinical Trial Evaluating TQB6411 Injection in Subjects With Esophageal Cancer
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
| Condition(s) | Esophageal Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * 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 Esophag |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Locations | Hefei, Anhui, China; Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Lanzhou, Gansu, China; Shantou, Guangdong, China; Nanning, Guangxi, China (+24 more sites) |
| Start date | 2026-02-12 |
| NCT ID | NCT07367516 |
| Official listing | https://clinicaltrials.gov/study/NCT07367516 |