TQB6411 injection for recurrent or metastatic esophageal cancer after PD‑1/PD‑L1 and platinum chemotherapy

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

This trial will try TQB6411 injections in people with recurrent or metastatic esophageal cancer whose disease progressed after PD‑1/PD‑L1 immunotherapy plus platinum chemotherapy to see if it is safe and helps control the cancer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 30 sites (Hefei, Anhui and 29 other locations)
• Trial ID: NCT07367516 on ClinicalTrials.gov

What this trial studies

This is a Phase Ib/II, open-label, multi-center trial of TQB6411 given by injection to adults with recurrent or metastatic esophageal cancer who previously failed PD‑1/PD‑L1 plus platinum chemotherapy. The Phase Ib portion focuses on safety and tolerability, while the Phase II portion tests efficacy in the same patient population. Eligible participants are ages 18–75 with ECOG 0–1, measurable disease by RECIST v1.1, and adequate organ function. The trial is being conducted at several cancer centers in China and uses standard clinical and imaging assessments to monitor response and adverse events.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–75 with histologically confirmed recurrent or metastatic esophageal cancer, ECOG 0–1, at least one measurable lesion, adequate organ function, and prior failure or intolerance of PD‑1/PD‑L1 inhibitor combined with platinum chemotherapy.

Not a fit: Patients with poor performance status (ECOG >1), significant organ dysfunction, or those who have not received prior PD‑1/PD‑L1 plus platinum therapy are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, TQB6411 could offer a new treatment option that is safe and helps shrink tumors or slow progression for patients who have exhausted PD‑1/PD‑L1 plus platinum chemotherapy.

How similar studies have performed: Some other investigational immunotherapies and targeted agents have shown activity in esophageal cancer, but TQB6411 is an investigational agent and its specific efficacy in this setting is unproven.

Eligibility criteria

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 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
* Subjects with any condition that may compromise venous access for drug administration or blood sampling are excluded.
* Subjects 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
* Subjects 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
* Subjects with active syphilis infection requiring antimicrobial therapy are excluded
* Subjects 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)
  * 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

Where this trial is running

Hefei, Anhui and 29 other locations

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

Study contacts

• Study coordinator: Feng Wang, Doctor

Conditions Esophageal Cancer