A Single-arm, Open-label, Multicenter Phase Ⅰb/Ⅱ Clinical Study of QL1706 (bispecific Antibody Targeting PD-1 and CLTA-4) in Combination with Lenvatinib in Second-line Therapy for Advanced Esophageal Squamous Cell Carcinoma After Disease Progression on Immune Checkpoint Blockades Therapy
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 49
- 主要终点
- Phase Ib：Dose Limiting Toxicities (DLTs) and recommended phase 2 dose (PR2D)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of QL1706 plus lenvatinib in second-line therapy for patients with metastatic esophageal squamous cell carcinoma after progression on immune checkpoint inhibitor therapy
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
- •Subjects participate voluntarily and sign informed consent.
- •18-75 years, male or female.
- •Histologically or cytologically verified diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma
- •Patients who have disease progression verified by imaging on standard first-line immunotherapy with anti-PD-1/PD-L1 antibodies
- •At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).
- •ECOG PS 0-1
排除标准
- •Presence of any active autoimmune disease or history of autoimmune disease (such as: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism)
- •Those who are taking immunosuppressants or systemic hormonal therapy for immunosuppressive purposes (dose> 10 mg/day prednisone or other equivalent cortiremonial hormones) and are taking within 2 weeks before recruitment
- •Severe allergic reaction to other monoclonal antibodies
- •Those who terminated treatment due to related toxicity during anti-PD-1/PD-L1 antibody treatment
- •Prior treatment with bispecific anti-PD-1/CTLA-4 checkpoint blockades or VEGFR inhibitors
研究组 & 干预措施
QL1706 plus Lenvatinib
QL1706 will be administrated at a dose of 5 mg/kg intravenously (IV), every 3 weeks, until progressive disease or intolerable or other reasons according to the criteria for termination of treatment. QL1706 will be administrated up to 2 year.
Lenvatinib will be administrated at a dose of 8 mg or 12mg orally (PO) once daily (QD)
干预措施: QL1706 (bispecific antibody targeting PD-1 and CLTA-4) (Drug)
QL1706 plus Lenvatinib
QL1706 will be administrated at a dose of 5 mg/kg intravenously (IV), every 3 weeks, until progressive disease or intolerable or other reasons according to the criteria for termination of treatment. QL1706 will be administrated up to 2 year.
Lenvatinib will be administrated at a dose of 8 mg or 12mg orally (PO) once daily (QD)
干预措施: Lenvatinib (Drug)
结局指标
主要结局
Phase Ib：Dose Limiting Toxicities (DLTs) and recommended phase 2 dose (PR2D)
时间窗: up to ~21 days
Hematologic DLTs are defined as: 1. Grade 4 neutropenia lasting for ≥7 days 2. febrile neutropenia not associated with the underlying disease, 3. Grade 3 thrombocytopenia with bleeding, Grade ≥3 thrombocytopenia requiring platelet transfusion, Grade 4 thrombocytopenia, .
Phase II: Overall Survival (OS) in all participants
时间窗: up to ~48 months
OS is defined as the time from the first administration to death due to any cause.
次要结局
- PFS(up to ~42 months)
- ORR(up to ~42 months)
- DOR(up to ~42 months)
- Number of Participants With AEs(Up to ~53 months)
研究者
Feng Wang
Professor
The First Affiliated Hospital of Zhengzhou University