A Randomized, Double-Blind, Parallel-Controlled, Multicenter Phase I Study to Evaluate the Pharmacokinetic Similarity Between QL1203 (Vectibix® Biosimilar Candidate) and Panitumumab (EU-Vectibix®) in Combination With mFOLFOX6 Respectively in Patients With RAS Wild-Type Metastatic Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 136
- 主要终点
- AUCtau, sd
研究概览
简要总结
This is a randomized, double-blind, parallel-controlled, multicenter clinical trial to evaluate the pharmacokinetic similarity between QL1203 and Vectibix® in patients with RAS wild-type metastatic colorectal cancer. Eligible trial participants will be randomized in a 1:1 ratio to either the QL1203 or Vectibix® groups, to received QL1203 + mFOLFOX6 and the control group received Vectibix® + mFOLFOX6. PK profiles, immunogenicity, safety and preliminary efficacy will be evaluated and compared between two groups .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate, have read, understood and signed the informed consent form (ICF), and are able to follow the study procedures.
- •Male or female aged ≥18 years.
- •Metastatic colorectal adenocarcinoma confirmed by histology or cytology, and not suitable for radical surgery, radiotherapy, radiofrequency ablation and other local treatments.
- •Wild-type RAS and wild-type BRAF.
- •At least 1 definite measurable tumor lesion according to RECIST v1.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-
- •Have adequate organ function.
排除标准
- •Previous systemic treatment: The time from the last dose of neoadjuvant or adjuvant therapy to disease recurrence is > 6 months.
- •Previous treatment with epidermal growth factor receptor (EGFR) targeted drugs for colorectal cancer.
- •Trial participants known to have high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR).
- •Presence of active central nervous system metastases.
- •Participants with a history of malignancies other than colorectal cancer within 5 years prior to the first dose.
- •Trial participants (both male and female) who are unwilling to accept effective contraception; female trial participants who are pregnant or breastfeeding.
研究组 & 干预措施
Test Group
干预措施: QL1203 + mFOLFOX6 (Drug)
Control Group
干预措施: Vectibix®+ mFOLFOX6 (Drug)
结局指标
主要结局
AUCtau, sd
时间窗: through the Cycle 1 (each cycle is 2 weeks)
Area under the serum concentration-time curve over one dosing interval after the first dose of QL1203 and Vectibix®
AUCtau,ss,
时间窗: through the Cycle 4 (each cycle is 2 weeks)
Area under the serum concentration-time curve over one dosing interval at steady state (at Cycle 4)
次要结局
未报告次要终点