A Multicenter, Open-label, Parallel-group，Randomised, Phase IIb Trial of Efficacy and Safety of Ametumumab in Combination With Anti-PD-1 Monoclonal Antibody and FOLFIRI Versus Ametumumab or Cetuximab in Combination With FOLFIRI in Patients With RAS Wild-type Advanced Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This is a multicenter, open-label, parallel-group, randomised, A phase IIb clinical trial of efficacy and safety of Ametumumab in combination with anti-PD-1 monoclonal antibody and FOLFIRI versus Ametumumab or Cetuximab in combination with FOLFIRI in patients with RAS wild-type advanced colorectal cancer.
详细描述
This is a multicenter, open-label, parallel-group, randomised, phase IIb trial. This study is to evaluate and compare the efficacy and safety of Ametumumab (anti-EGFR monoclonal antibody) combined with anti-PD-1 monoclonal antibody in first-line treatment of RAS wild-type colorectal cancer patients, as well as to assess the immunogenicity and pharmacokinetic profile and recommend dosing regimen for phase III clinical trials.Conditions and keywords.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign written informed consent; Age 18 ~ 85 years (inclusive), male or female;
- •Patients requiring first-line treatment for locally advanced colorectal cancer with distant metastasis or unresectable disease; Histologically or cytologically confirmed adenocarcinoma of the colon or rectum; RAS (KRAS, NRAS) gene is wild-type and no BRAF V600E mutation has been identified; Presence of at least one measurable lesion (non-radiation field) confirmed by CT or MRI that meets RECIST 1.1 criteria; Performance status (ECOG) score 0 or 1.
排除标准
- •Previous chemotherapy for colorectal cancerPrevious treatment with anti-EGFR monoclonal antibodies Received systemic anti-tumor treatment approved or of other clinical studies within 4 weeks prior to the first dose.
- •Radiotherapy or surgery within 4 weeks prior to enrollment, except for diagnostic biopsy Participation in other clinical trials within 4 weeks prior to enrollment; Severe skin disease requiring systemic treatment. Presence of serious clinical infection.\ Uncontrolled pleural effusion, pericardial effusion or peritoneal effusion after treatment.
研究组 & 干预措施
Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI
Ametumumab 450 mg/m2 (QW) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI;
干预措施: Ametumumab (Drug)
Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI
Ametumumab 450 mg/m2 (QW) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI;
干预措施: Anti-PD-1 monoclonal antibody (Drug)
Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI
Ametumumab 450 mg/m2 (QW) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI;
干预措施: FOLFIRI (Drug)
Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI;
Ametumumab 450 mg/m2 (Q2W) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI;
干预措施: Ametumumab (Drug)
Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI;
Ametumumab 450 mg/m2 (Q2W) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI;
干预措施: Anti-PD-1 monoclonal antibody (Drug)
Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI;
Ametumumab 450 mg/m2 (Q2W) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI;
干预措施: FOLFIRI (Drug)
Ametumumab (Q2W) + FOLFIRI;
Ametumumab 450 mg/m2 (Q2W) + FOLFIRI
干预措施: Ametumumab (Drug)
Ametumumab (Q2W) + FOLFIRI;
Ametumumab 450 mg/m2 (Q2W) + FOLFIRI
干预措施: FOLFIRI (Drug)
Cetuximab + FOLFIRI;
Cetuximab 500 mg/m2 (Q2W) + FOLFIRI
干预措施: Cetuximab (Drug)
Cetuximab + FOLFIRI;
Cetuximab 500 mg/m2 (Q2W) + FOLFIRI
干预措施: FOLFIRI (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: PFS will be measured from the date of first dose of study drug until first documented clinical or radiographic evidence of disease progression by RECIST 1.1, clinical progression, start of new therapy or death. approximately 45 months
次要结局
- Objective Response Rate (ORR)(ORR is defined as a CR or PR per RECIST version 1.1 recorded from the date of randomization until date of first documentation of PD, death, or start of new anti-cancer therapy, approximately 45 months.)
- incidence of adverse events(Incidence and severity of AEs graded according to the NCI CTCAE v5.0, Duration of study, approximately 45 months)