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
1 other identifier
interventional
105
1 country
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2026
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2026
CompletedFirst Posted
Study publicly available on registry
January 26, 2026
CompletedStudy Start
First participant enrolled
February 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
March 4, 2026
December 1, 2025
7 months
January 18, 2026
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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.
3 mouths
Incidence and severity of adverse events
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)
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 Outcomes (9)
Objective Response Rate (ORR)
24 mouths
Disease Control Rate(Disease Control Rate=achieving Complete Response [CR] or+Partial Response [PR]+Stable Disease (SD)
24 mouths
Duration of Response (DOR)
24 mouths
Overall Survival (OS)
24 mouths
Peak plasma concentration (Cmax)
Within 14 days after administration
- +4 more secondary outcomes
Study Arms (1)
TQB6411 Injection
EXPERIMENTALTQB6411 Injection , 21 days as a treatment cycle.
Interventions
TQB6411 Injection is an antibody-drug conjugate (ADC) targeting Epidermal Growth Factor Receptor (EGFR)/c-Met.
Eligibility Criteria
You may qualify if:
- 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.
- +1 more criteria
You may not qualify if:
- 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)
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230061, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350000, China
Gansu Provincial Tumor Hospital
Lanzhou, Gansu, 730050, China
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515000, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021, China
Guizhou Provincial People's Hospital
Guangxi, Guizhou, 550002, China
The Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563006, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Anyang Cancer Hospital
Anyang, Henan, 455000, China
The Second People's Hosital of Jiaozuo
Jiaozuo, Henan, 454001, China
Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
Luoyang, Henan, 471000, China
The first affiliated hospital of Zhengzhou university
Zhengzhou, Henan, 450000, China
Zhengzhou Central Hospital
Zhengzhou, Henan, 450000, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410005, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000, China
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, 210019, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225009, China
The first hospital of jilin university
Changchun, Jilin, 130012, China
Jilin Cancer Hospital
Changchun, Jilin, 130021, China
Linyi cancer Hospital
Liyi, Shandong, 276034, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000, China
The Second Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, 710000, China
Sichuan cancer hosipital
Chengdu, Sichuan, 610040, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 64600, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Zhongshan Hospital Fudan University
Shanghai, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2026
First Posted
January 26, 2026
Study Start
February 12, 2026
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
March 4, 2026
Record last verified: 2025-12