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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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