Clinical Trial Evaluating TQB6411 Injection in Subjects With Esophageal Cancer

March 3, 2026 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200032
        • Not yet recruiting
        • Zhongshan Hospital Fudan University
        • Contact:
    • Anhui
      • Hefei, Anhui, China, 230061
        • Not yet recruiting
        • The Second Affiliated Hospital of Anhui Medical University
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Not yet recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Not yet recruiting
        • Gansu Provincial Tumor Hospital
        • Contact:
    • Guangdong
      • Shantou, Guangdong, China, 515000
        • Not yet recruiting
        • The First Affiliated Hospital of Shantou University Medical College
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
    • Guizhou
      • Guangxi, Guizhou, China, 550002
        • Not yet recruiting
        • Guizhou Provincial People's Hospital
        • Contact:
      • Zunyi, Guizhou, China, 563006
        • Not yet recruiting
        • The Second Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Henan
      • Anyang, Henan, China, 455000
        • Not yet recruiting
        • Anyang Cancer Hospital
        • Contact:
      • Jiaozuo, Henan, China, 454001
        • Not yet recruiting
        • The Second People's Hosital of Jiaozuo
        • Contact:
      • Luoyang, Henan, China, 471000
        • Not yet recruiting
        • Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • Zhengzhou Central Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410005
        • Not yet recruiting
        • Hunan Provincial People's Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • Jiangsu Cancer Hospital
        • Contact:
      • Nanjing, Jiangsu, China, 210019
        • Not yet recruiting
        • Jiangsu Provincial Hospital of Traditional Chinese Medicine
        • Contact:
      • Yangzhou, Jiangsu, China, 225009
        • Not yet recruiting
        • Northern Jiangsu People's Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • Not yet recruiting
        • Jilin Cancer Hospital
        • Contact:
      • Changchun, Jilin, China, 130012
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
    • Shandong
      • Liyi, Shandong, China, 276034
        • Not yet recruiting
        • Linyi Cancer Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Not yet recruiting
        • Shanghai Chest Hospital
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Not yet recruiting
        • Shanxi Bethune Hospital
        • Contact:
      • Xi’an, Shanxi, China, 710000
        • Not yet recruiting
        • The Second Affiliated Hospital of Air Force Medical University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Not yet recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
      • Chengdu, Sichuan, China, 610040
        • Not yet recruiting
        • Sichuan cancer hosipital
        • Contact:
      • Luzhou, Sichuan, China, 64600
        • Not yet recruiting
        • Affiliated Hospital of Southwest Medical University
        • Contact:
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300000
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
        • Contact:
          • Xuebang Zhang, Master
          • Phone Number: 13777760353
          • Email: Baxuza@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQB6411 Injection
TQB6411 Injection , 21 days as a treatment cycle.
Drug: TQB6411 Injection
TQB6411 Injection is an antibody-drug conjugate (ADC) targeting Epidermal Growth Factor Receptor (EGFR)/c-Met.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recommended Phase 2 Dose (RP2D)
Time Frame: 3 mouths
The RP2D is defined as the recommended dose for subsequent Phase II studies, which will be determined based on a comprehensive assessment of Pharmacokinetics (PK), preliminary efficacy, and safety.
3 mouths
Incidence and severity of adverse events
Time Frame: 24 mouths
This study requires the collection of any adverse medical events occurring from the time the subject signs the informed consent form until 30 days after the last dose of study medication or the initiation of new anti-tumor therapy, whichever comes first.
24 mouths
Progression-Free Survival (PFS)
Time Frame: 24 mouths
PFS is defined as the time from the first administration of treatment to the first occurrence of disease progression or death from any cause, whichever comes first, as determined by the investigator according to RECIST 1.1.
24 mouths

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak time (Tmax)
Time Frame: Within 14 days after administration
It refers to the time when the maximum blood drug concentration is reached after administration of TQB6411 for injection.
Within 14 days after administration
Objective Response Rate (ORR)
Time Frame: 24 mouths
Proportion of patients with objective response(achieving Complete Response (CR) + Partial Response (PR) out of the total number of cases and 95% Confidence Interval (CI).
24 mouths
Disease Control Rate(Disease Control Rate=achieving Complete Response [CR] or+Partial Response [PR]+Stable Disease (SD)
Time Frame: 24 mouths
Proportion of patients with disease control (achieving Complete Response [CR] or+Partial Response [PR]+Stable Disease[SD] out of the total number of cases and 95% CI.
24 mouths
Duration of Response (DOR)
Time Frame: 24 mouths
DOR refers to the time interval from the first documentation of disease remission (achieving Complete Response [CR] or Partial Response [PR]) to the time of disease relapse or progression (PD).
24 mouths
Overall Survival (OS)
Time Frame: 24 mouths
Overall Survival (OS) refers to the length of time from the date of diagnosis or the start of treatment for a disease (such as cancer) until the patient's death from any cause.
24 mouths
Peak plasma concentration (Cmax)
Time Frame: Within 14 days after administration
It refers to the highest blood drug concentration achieved after administration of TQB6411 injection.
Within 14 days after administration
Area Under the Concentration-time Curve (AUC0-t)
Time Frame: Within 14 days after administration
Area under the drug concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) after a single dose.
Within 14 days after administration
Area Under the Concentration-time Curve (AUC0-∞)
Time Frame: Within 14 days after administration
Area under the drug concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)
Within 14 days after administration
Number of subjects with incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Time Frame: 24 months
Number and proportion of subjects positive for anti-drug antibodies (ADA) after treatment, along with 95% confidence intervals, and a description of the time of onset, titer, etc., of anti-drug antibody (ADA) development.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB6411-Ib/II-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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