Clinical Trial Evaluating TQB6411 Injection in Subjects With Esophageal Cancer

CTTQ

Status and phase

Begins enrollment this month

Phase 2

Phase 1

Conditions

Esophageal Cancer

Treatments

Drug: TQB6411 Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT07367516

TQB6411-Ib/II-01

Details and patient eligibility

About

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.

Enrollment

105 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.
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
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)
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