RecruitingPhase 1Phase 2NCT07367516

Clinical Trial Evaluating TQB6411 Injection in Subjects With Esophageal Cancer

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


Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Enrollment

105 participants

Start Date

Feb 12, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called TQB6411 for people with recurrent or metastatic esophageal cancer — cancer of the tube connecting the throat to the stomach — that has come back or spread after prior treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed esophageal cancer that has returned or spread - Your cancer is measurable on scans - You are in good overall condition (ECOG 0–1) with expected survival over 12 weeks - Your blood counts and organ function meet the required levels **You may NOT be eligible if...** - Your cancer is not measurable on imaging - Your blood counts, liver enzymes, or kidney function are below required thresholds - You have an active serious infection or autoimmune disease - You are pregnant or breastfeeding - You have had recent major surgery or other cancer treatments that would interfere Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQB6411 Injection

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


Locations(30)

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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NCT07367516


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