Esophageal CancerPhase 1/2NCT07367516
Clinical Trial Evaluating TQB6411 Injection in Participant s With Esophageal Cancer
A Phase 1/2 study testing TQB6411 Injection in people with Esophageal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 30 sites in China.
Trial summary
The Phase Ib stage of this study primarily aims to evaluate the tolerance and safety of TQB6411 Injection in participants with recurrent or metastatic Esophageal cancer who have previously failed treatment with PD-1/PD-L1 monoclonal antibodies combined with platinum-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- TQB6411 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 30 sitesChina
- Study dates
- 12 Feb 2026to Mar 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants 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)：
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- 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.
Who cannot join
- Current or History of Other Malignancies
- Participants with any condition that may compromise venous access for drug administration or blood sampling are excluded.
- Participants 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
- Participants 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
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- Poorly Controlled Active Viral Hepatitis
- Participants with active syphilis infection requiring antimicrobial therapy are excluded
- Participants 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)
- Participants with tracheal or esophageal stent placement for any reason, except for stent placement performed for benign cicatricial stricture.
- Participants with esophageal fistula caused by tumor invasion into adjacent organs of the esophagus (including trachea, bronchus, mediastinum, pleura, chest wall, pericardium, aorta, etc.), or patients assessed by the investigator to be at risk of developing esophageal fistula.
- 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
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
China30 sites, 30 recruiting
- Not yet recruiting
Anyang Cancer Hospital
Anyang, Henan, 455000
Jin Xia, Master, 15890750990, 15890750990@126.com
- Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Jing Huang, Doctor, 13301056087, huangjingwg@163.com
- Not yet recruiting
The first hospital of jilin university
Changchun, Jilin, 130012
Wei Li, Doctor, 13756661267, jdyylw@163.com
- Not yet recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130021
Haifeng Liu, Master, 0431-80596336, HFLIU2025@163.com
- Not yet recruiting
Hunan Provincial People's Hospital
Changsha, Hunan, 410005
Huaxin Duan, Doctor, 13347315509, 317102912@qq.com
- Not yet recruiting
Sichuan cancer hosipital
Chengdu, Sichuan, 610040
Qifeng Wang, Doctor, 18227667667, littlecancer@163.com
- Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Xueqiang Zhu, Master, 189 8183 8387, zhuxueqiang1234@163.com
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350000
Zhangzhou Huang, Bachelor, 13609578088, 1609305255@qq.com
- Not yet recruiting
Guizhou Provincial People's Hospital
Guangxi, Guizhou, 550002
Yu Zhang, Doctor, 18885146684, 248634489@qq.com
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Zhiwei Li, Doctor, 15004683651, lzhw0451@163.com
- Not yet recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230061
Mingjun Zhang, Master, 13865952007, mjzhang2010@outlook.com
- Not yet recruiting
The Second People's Hosital of Jiaozuo
Jiaozuo, Henan, 454001
Li Li, Doctor, 18603912883, liliwqf@163.com
- Not yet recruiting
Gansu Provincial Tumor Hospital
Lanzhou, Gansu, 730050
Zhihu Li, Master, 18993042850, 245698692@qq.com
- Not yet recruiting
Linyi cancer Hospital
Liyi, Shandong, 276034
Shuhong Liu, Master, 13953959036, liushuhonglz.2008@163.com
- Not yet recruiting
Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
Luoyang, Henan, 471000
Tiejun Ren, Master, 13937967667, lysrtj@126.com
- Not yet recruiting
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 64600
Peirong Ren, Master, 15883037066, 1097802221@qq.com
Qing Peng, Doctor, 18181873310, qingpeng9712118@163.com
- Not yet recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000
Xiaohua Wang, Doctor, 13676799069, wangxiaohua@jszlyy.com.cn
- Not yet recruiting
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, 210019
Jun Qian, Doctor, 13951702380, 1836141816@qq.com
- Not yet recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
Jiangqiong Huang, Doctor, 13978809340, 947095887@qq.com
- Not yet recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Xuwei Cai, Doctor, 13817512612, birdhome2000@163.com
- Not yet recruiting
Zhongshan Hospital Fudan University
Shanghai, 200032
Tianshu Liu, Doctor, 13681973996, liu.tianshu@zs-hospital.sh.cn
- Not yet recruiting
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515000
Liming Chen, Doctor, 13923909199, angelchen08@sina.com
- Not yet recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000
Yarong Guo, Doctor, 13453410624, gyr5258@126.com
- Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300000
Ting Deng, Doctor, 15802243063, xymcdengting@126.com
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Liping Tao, Master, 13676799069, drlipingtao@163.com
Xuebang Zhang, Master, 13777760353, Baxuza@126.com
- Not yet recruiting
The Second Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, 710000
Haichuan Su, Doctor, 18629190366, cntdgcp@163.com
- Not yet recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225009
Xianwen Zhang, Doctor, 18051060926, zhangxwok@163.com
- Recruiting
The first affiliated hospital of Zhengzhou university
Zhengzhou, Henan, 450000
Feng Wang, Doctor, 13938244776, fengw010@163.com
- Not yet recruiting
Zhengzhou Central Hospital
Zhengzhou, Henan, 450000
Fang Liang, Master, 13938203863, fangfang0800@sina.com
- Not yet recruiting
The Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563006
Zhou Jianguo, Doctor, 18785237902, jianguo905@163.com
About this study
Official title: A Phase Ib/II Clinical Trial Evaluating the Safety and Efficacy of TQB6411 Injection in Participant s 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 participants 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 participants population.
- Conditions
- Esophageal Cancer
- Being tested
- TQB6411 Injection
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB6411 InjectionDrug
TQB6411 Injection is an antibody-drug conjugate (ADC) targeting Epidermal Growth Factor Receptor (EGFR)/c-Met.
| Study group | Role | What they receive |
|---|---|---|
| TQB6411 Injection | Experimental | TQB6411 Injection, 21 days as a treatment cycle.
TQB6411 injection, 28 days as a treatment cycle. Receives: Drug: TQB6411 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose (RP2D)
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.
Measured: 3 mouths
Incidence and severity of adverse events
This study requires the collection of any adverse medical events occurring from the time the participant 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.
Measured: 24 mouths
Progression-Free Survival (PFS)
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.
Measured: 24 mouths
Secondary outcomes (9)
Objective Response Rate (ORR)
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).
Measured: 24 mouths
Disease Control Rate(Disease Control Rate=achieving Complete Response [CR] or+Partial Response [PR]+Stable Disease (SD)
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.
Measured: 24 mouths
Duration of Response (DOR)
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).
Measured: 24 mouths
Overall Survival (OS)
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.
Measured: 24 mouths
Peak plasma concentration (Cmax)
It refers to the highest blood drug concentration achieved after administration of TQB6411 injection.
Measured: Within 14 days after administration
Area Under the Concentration-time Curve (AUC0-t)
Area under the drug concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) after a single dose.
Measured: Within 14 days after administration
Area Under the Concentration-time Curve (AUC0-∞)
Area under the drug concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)
Measured: Within 14 days after administration
Peak time (Tmax)
It refers to the time when the maximum blood drug concentration is reached after administration of TQB6411 for injection.
Measured: Within 14 days after administration
Number of subjects with incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start12 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367516
- Sponsor's protocol ID
- TQB6411-Ib/II-01
- Status last verified
- Sep 2026
- First submitted
- 18 Jan 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No