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.
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
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
Single group
TQB6411 Injection
DrugTQB6411 Injection is an antibody-drug conjugate (ADC) targeting Epidermal Growth Factor Receptor (EGFR)/c-Met.
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.
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.
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.
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).
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.
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).
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.
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