RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

Clinical Trial Evaluating TQB6411 Injection in Participant s With Esophageal Cancer

Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. • ClinicalTrials.gov ID: NCT07367516

Registry updated: 2026-09-15

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Description

The Phase Ib stage of this study primarily aims to evaluate the tolerance and safety of TQB6411 Injection in participants 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 participants population.

Interventions

TQB6411 Injection (Drug)
TQB6411 Injection is an antibody-drug conjugate (ADC) targeting Epidermal Growth Factor Receptor (EGFR)/c-Met.

Eligibility criteria

Inclusion Criteria: * Participants 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. Exclusion Criteria: * Current or History of Other Malignancies * Participants with any condition that may compromise venous access for drug administration or blood sampling are excluded. * Participants with prior treatment-related adverse reactions that have not recovered to ≤ Grade 1 per CTCAE v5.0 criteria. * Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose, Scheduled major surgery during the study intervention period, Non-healing wound, ulcer, or bone fracture at screening * Participants with any bleeding/hemorrhagic event ≥ Grade 3 (per CTCAE v5.0) occurring within 4 weeks before the first dose are excluded * History of Thromboembolic Events within 6 Months * Poorly Controlled Active Viral Hepatitis * Participants with active syphilis infection requiring antimicrobial therapy are excluded * Participants with any of the following pulmonary conditions are excluded: active tuberculosis, idiopathic pulmonary fibrosis (IPF), organizing pneumonia, drug-induced/radiation pneumonitis requiring treatment, symptomatic active pneumonia, or history of interstitial lung disease (ILD) requiring therapy * History of Substance Abuse or Psychiatric Disorders * History of Allogeneic Transplantation (Bone Marrow or Solid Organ) * History of Hepatic Encephalopathy * Major Cardiovascular Diseases * Active or Uncontrolled Severe Infections * Renal Failure Requiring Dialysis (Hemodialysis/Peritoneal Dialysis) * History of Immunodeficiency * Poorly Controlled Autoimmune Disease * Poorly Controlled Autoimmune Disease \& Epilepsy Requiring Treatment * Poorly Controlled Diabetes * Tumor-Related Symptoms and Treatment Considerations： * Exclusion Criterion - Recent Anticancer Treatment (≤3 Weeks or Within 5 Half-Lives) * Recent Use of National Medical Products Administration (NMPA) -Approved Anticancer Traditional Chinese Medicine (≤1 Week Prior to Treatment) * Participants with tracheal or esophageal stent placement for any reason, except for stent placement performed for benign cicatricial stricture. * Participants with esophageal fistula caused by tumor invasion into adjacent organs of the esophagus (including trachea, bronchus, mediastinum, pleura, chest wall, pericardium, aorta, etc.), or patients assessed by the investigator to be at risk of developing esophageal fistula. * Radiologically Confirmed Tumor Encasement of Major Vessels with High Bleeding Risk * Uncontrolled Effusions Requiring Repeated Drainage * Known to have spinal cord compression, leptomeningeal metastasis/carcinomatous meningitis, or symptomatic brain metastases with less than 4 weeks of symptom/imaging control. * Known Hypersensitivity to Investigational Drug or Excipients * Prior Treatment with Topoisomerase I Inhibitor-Based ADCs and/or Irinotecan Chemotherapy * Prior Participation in Anticancer Clinical Trials Within 4 Weeks * Investigator-Assessed Safety or Compliance Concerns

Conditions

Esophageal Cancer

Locations

The Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China
Fujian Cancer Hospital — Fuzhou, Fujian, China
Gansu Provincial Tumor Hospital — Lanzhou, Gansu, China
The First Affiliated Hospital of Shantou University Medical College — Shantou, Guangdong, China
Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China
Guizhou Provincial People's Hospital — Guangxi, Guizhou, China
The Second Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China
Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
Anyang Cancer Hospital — Anyang, Henan, China
The Second People's Hosital of Jiaozuo — Jiaozuo, Henan, China
Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital) — Luoyang, Henan, China
The first affiliated hospital of Zhengzhou university — Zhengzhou, Henan, China
Zhengzhou Central Hospital — Zhengzhou, Henan, China
Hunan Provincial People's Hospital — Changsha, Hunan, China
Jiangsu Cancer Hospital — Nanjing, Jiangsu, China
Jiangsu Provincial Hospital of Traditional Chinese Medicine — Nanjing, Jiangsu, China
Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China
The first hospital of jilin university — Changchun, Jilin, China
Jilin Cancer Hospital — Changchun, Jilin, China
Linyi cancer Hospital — Liyi, Shandong, China
Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital — Taiyuan, Shanxi, China
The Second Affiliated Hospital of Air Force Medical University — Xi’an, Shanxi, China
Sichuan cancer hosipital — Chengdu, Sichuan, China
Sichuan Provincial People's Hospital — Chengdu, Sichuan, China
Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China
Zhongshan Hospital Fudan University — Shanghai, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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