NCT07367516招募中1 期
A Phase Ib/II Clinical Trial Evaluating the Safety and Efficacy of TQB6411 Injection in Participant s With Recurrent or Metastatic Esophageal Cancer Who Have Failed Prior PD-1/PD-L1 Inhibitor Plus Platinum-Based Chemotherapy
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 30
- 主要终点
- Recommended Phase 2 Dose (RP2D)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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
- •Participants 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
- •Participants with active syphilis infection requiring antimicrobial therapy are excluded
- •Participants 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)
- •Participants with tracheal or esophageal stent placement for any reason, except for stent placement performed for benign cicatricial stricture.
- •Participants with esophageal fistula caused by tumor invasion into adjacent organs of the esophagus (including trachea, bronchus, mediastinum, pleura, chest wall, pericardium, aorta, etc.), or patients assessed by the investigator to be at risk of developing esophageal fistula.
- •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
研究组 & 干预措施
TQB6411 Injection
Experimental
TQB6411 Injection, 21 days as a treatment cycle.
TQB6411 injection, 28 days as a treatment cycle.
干预措施: TQB6411 Injection (Drug)
结局指标
主要结局
Recommended Phase 2 Dose (RP2D)
时间窗: 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
时间窗: 24 mouths
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)
时间窗: 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.
次要结局
- 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)
研究者
研究点 (30)
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