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
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 105
- Locations
- 30
- Primary Endpoint
- Recommended Phase 2 Dose (RP2D)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
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
Arms & Interventions
TQB6411 Injection
TQB6411 Injection , 21 days as a treatment cycle.
Intervention: TQB6411 Injection (Drug)
Outcomes
Primary Outcomes
Recommended Phase 2 Dose (RP2D)
Time Frame: 3 mouths
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
Time Frame: 24 mouths
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.
Progression-Free Survival (PFS)
Time Frame: 24 mouths
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.
Secondary Outcomes
- 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)
- Area Under the Concentration-time Curve (AUC0-t)(Within 14 days after administration)
- Area Under the Concentration-time Curve (AUC0-∞)(Within 14 days after administration)
- Peak time (Tmax)(Within 14 days after administration)
- Number of subjects with incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)(24 months)