New hope for tough esophageal cancer: targeted drug trial launches
NCT ID NCT07367516
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests a new drug called TQB6411 in people with advanced esophageal cancer that has worsened after standard treatments. The drug is designed to target and attack cancer cells. The trial has two parts: first to find a safe dose, then to see if it shrinks tumors. About 105 participants will be enrolled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TQB6411 (an antibody-drug conjugate targeting EGFR/c-Met)
- What this could lead to
- If successful, this could provide a new treatment option for people with esophageal cancer that has not responded to standard therapies.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the drug may not prove effective or may cause significant side effects. It is not a cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 105 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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)： * 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 * 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 * 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) * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
30 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Locations
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Affiliated Hospital of Southwest Medical University
NOT_YET_RECRUITINGLuzhou, Sichuan, 64600, China
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Anyang Cancer Hospital
NOT_YET_RECRUITINGAnyang, Henan, 455000, China
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Cancer Hospital Chinese Academy of Medical Sciences
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100021, China
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Fujian Cancer Hospital
NOT_YET_RECRUITINGFuzhou, Fujian, 350000, China
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Gansu Provincial Tumor Hospital
NOT_YET_RECRUITINGLanzhou, Gansu, 730050, China
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Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITINGNanning, Guangxi, 530021, China
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Guizhou Provincial People's Hospital
NOT_YET_RECRUITINGGuangxi, Guizhou, 550002, China
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Harbin Medical University Cancer Hospital
NOT_YET_RECRUITINGHarbin, Heilongjiang, 150000, China
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Hunan Provincial People's Hospital
NOT_YET_RECRUITINGChangsha, Hunan, 410005, China
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Jiangsu Cancer Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, 210000, China
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Jiangsu Provincial Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITINGNanjing, Jiangsu, 210019, China
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Jilin Cancer Hospital
NOT_YET_RECRUITINGChangchun, Jilin, 130021, China
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Linyi cancer Hospital
NOT_YET_RECRUITINGLiyi, Shandong, 276034, China
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Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
NOT_YET_RECRUITINGLuoyang, Henan, 471000, China
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Northern Jiangsu People's Hospital
NOT_YET_RECRUITINGYangzhou, Jiangsu, 225009, China
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Shanghai Chest Hospital
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200030, China
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Shanxi Bethune Hospital
NOT_YET_RECRUITINGTaiyuan, Shanxi, 030000, China
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Sichuan Provincial People's Hospital
NOT_YET_RECRUITINGChengdu, Sichuan, 610072, China
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Sichuan cancer hosipital
NOT_YET_RECRUITINGChengdu, Sichuan, 610040, China
Contact Email: •••••@•••••
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The First Affiliated Hospital of Shantou University Medical College
NOT_YET_RECRUITINGShantou, Guangdong, 515000, China
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The First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITINGWenzhou, Zhejiang, 325000, China
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The Second Affiliated Hospital of Air Force Medical University
NOT_YET_RECRUITINGXi’an, Shanxi, 710000, China
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The Second Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITINGHefei, Anhui, 230061, China
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The Second Affiliated Hospital of Zunyi Medical University
NOT_YET_RECRUITINGZunyi, Guizhou, 563006, China
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The Second People's Hosital of Jiaozuo
NOT_YET_RECRUITINGJiaozuo, Henan, 454001, China
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The first affiliated hospital of Zhengzhou university
RECRUITINGZhengzhou, Henan, 450000, China
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The first hospital of jilin university
NOT_YET_RECRUITINGChangchun, Jilin, 130012, China
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Tianjin Medical University Cancer Institute & Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, 300000, China
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Zhengzhou Central Hospital
NOT_YET_RECRUITINGZhengzhou, Henan, 450000, China
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Zhongshan Hospital Fudan University
NOT_YET_RECRUITINGShanghai, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug shrink tumors that resist standard care?
- Could the anesthesia used during surgery influence whether esophageal cancer returns?
- Can an oral drug R01 fight advanced lung, stomach, and esophageal cancers?
- A single blood draw to detect five cancers before symptoms appear?
- Can custom vitamin pills fix nutrient gaps after stomach or esophageal cancer surgery?
- Can repeated MRI scans reveal how tumors respond to radiation?