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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
TQB6411 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 mouths
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).
Time frame: 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.
Time frame: 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).
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The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
NOT_YET_RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGGansu Provincial Tumor Hospital
Lanzhou, Gansu, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
NOT_YET_RECRUITINGGuangxi Medical University Cancer Hospital
Nanning, Guangxi, China
NOT_YET_RECRUITINGGuizhou Provincial People's Hospital
Guangxi, Guizhou, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
NOT_YET_RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGAnyang Cancer Hospital
Anyang, Henan, China
NOT_YET_RECRUITING...and 20 more locations
Time frame: 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.
Time frame: 24 mouths
Peak plasma concentration (Cmax)
It refers to the highest blood drug concentration achieved after administration of TQB6411 injection.
Time frame: 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.
Time frame: 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-∞)
Time frame: 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.
Time frame: 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.
Time frame: 24 months