What is TQB6411 Injection studying for Esophageal Cancer?

TQB6411 Injection is being studied to assess its safety, tolerance, and effectiveness in adults with recurrent or metastatic Esophageal Cancer who have not responded to previous treatments including PD-1/PD-L1 inhibitors and platinum chemotherapy. The research is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and aims to find better treatment options for this condition.

Who may be eligible for this Esophageal Cancer clinical trial?

Adults aged 18 to 75 with recurrent or metastatic Esophageal Cancer who have previously been treated with PD-1/PD-L1 inhibitors plus platinum chemotherapy may be eligible. Participants should have good physical health with an ECOG score of 0 or 1 and expected survival of more than 12 weeks. Please review eligibility criteria for more details.

Is there any cost to participate in this Esophageal Cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 75Years

All Genders

ID07367516

Safety and Effectiveness of TQB6411 Injection in Adults with Recurrent or Metastatic Esophageal Cancer After Prior PD-1PD-L1 and Platinum Therapy

Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2026-07-02

105

Participants Needed

Research Sites

25 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating TQB6411 Injection in adults with recurrent or metastatic Esophageal Cancer who have previously not responded to PD-1PD-L1 monoclonal antibodies combined with platinum-based chemotherapy. The study includes Phase Ib to assess tolerance and safety, and Phase II to evaluate the effectiveness of TQB6411 Injection in this participant group. Participants will receive TQB6411 Injection administered in treatment cycles of either 21 or 28 days. The study follows a single group model where all participants receive the investigational drug. The research aims to determine the recommended dose for Phase II, monitor adverse events, and assess progression-free survival over 24 months. Participants will be involved in treatment and regular assessments including laboratory tests, tumor measurements according to RECIST v1.1, and biomarker analysis using tumor tissue samples. The study measures include response rates, survival outcomes, and drug concentration in plasma. Safety monitoring continues for up to 24 months, and participants must comply with study procedures and contraception requirements during and after the study.

CONDITIONS

Brief Title

Clinical Trial Evaluating TQB6411 Injection in Participant s With Esophageal Cancer

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Participants voluntarily participate in this study and sign informed consent
Age between 18 and 75 years old inclusive
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Expected survival longer than 12 weeks
At least one measurable tumor lesion according to RECIST v1.1
Laboratory values within specified limits without recent hematopoietic growth factor correction
Histologically or cytologically confirmed recurrent or metastatic Esophageal cancer
Failure or intolerance to prior PD-1/PD-L1 inhibitor plus platinum-based chemotherapy for recurrent/metastatic Esophageal cancer
Willingness to provide archived or fresh tumor tissue for biomarker analysis
For females of childbearing potential, negative pregnancy test within 7 days before enrollment and agreement to use effective contraception during and for 6 months after the study
Males agree to use effective contraception during and for 6 months after the study

You will not qualify if you...

Current or history of other malignancies
Conditions compromising venous access for drug administration or blood sampling
Unresolved treatment-related adverse reactions above Grade 1 per CTCAE v5.0
Major surgery or significant trauma within 4 weeks before first dose or planned major surgery during study
Non-healing wounds, ulcers, or bone fractures at screening
Bleeding events of Grade 3 or higher within 4 weeks before first dose
History of thromboembolic events within 6 months
Poorly controlled active viral hepatitis
Active syphilis infection requiring antimicrobial therapy
Pulmonary conditions including active tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced or radiation pneumonitis needing treatment, symptomatic pneumonia, or interstitial lung disease requiring therapy
History of substance abuse or psychiatric disorders
History of allogeneic transplantation
History of hepatic encephalopathy
Major cardiovascular diseases
Active or uncontrolled severe infections
Renal failure requiring dialysis
History of immunodeficiency
Poorly controlled autoimmune disease or epilepsy requiring treatment
Poorly controlled diabetes
Recent anticancer treatment within 3 weeks or within 5 half-lives
Recent use of approved anticancer traditional Chinese medicine within 1 week prior to treatment
Tumor-related conditions posing high bleeding risk or uncontrolled effusions requiring repeated drainage
Known spinal cord compression, leptomeningeal metastasis, symptomatic brain metastases without 4 weeks control
Known hypersensitivity to investigational drug or excipients
Prior treatment with topoisomerase I inhibitor-based ADCs or irinotecan chemotherapy
Participation in anticancer clinical trials within 4 weeks
Investigator-assessed safety or compliance concerns

Research Team

Feng Wang, Doctor

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Safety and Effectiveness of TQB6411 Injection in Adults with Recurrent or Metastatic Esophageal Cancer After Prior PD-1PD-L1 and Platinum Therapy

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria