NCT04985825撤回2 期
Phase 2 Study of Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma (I-PACE)
Pega-One S.A.S.0 个研究点开始时间: 2021年12月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Overall Response Rate (ORR) assessed by the Independent Central Review Committee (ICRC) according to the Study Response Criteria
研究概览
简要总结
This study will evaluate the anti-tumor activity, safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of imgatuzumab, a monoclonal antibody against epidermal growth factor receptor (EGFR) with enhanced antibody-dependent cellular cytotoxicity (ADCC) in patients with advanced cutaneous squamous cell carcinoma (CSCC). Quality of life of patients treated with imgatuzumab will also be assessed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of CSCC
- •CSCC of advanced stage
- •Males or females at least 18 years of age at the time of consent
- •Signed informed consent provided prior to any study procedures
- •Ability to and willing to understand informed consent and comply with protocol requirements and procedures
- •No more than two prior lines of systemic treatment for advanced disease
- •Patients must have at least one lesion that is considered as measurable according to the Study Response Criteria
- •Eastern Cooperative Oncology Group performance status 0 or 1
- •Adequate function of bone marrow, liver, kidneys
- •Availability of tumor tissue sample (either an archival specimen or a fresh biopsy material) at Screening
排除标准
- •Prior systemic treatment for advanced disease with any anti-EGFR agent
- •Active central nervous system metastasis
- •Systemic anti-cancer therapy within five half-lives or two weeks, whichever is shorter, prior to first dose of the study drug
- •Persistent toxicities from previous systemic anti-neoplastic treatments
- •Wide-field radiotherapy within four weeks, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within two weeks prior to first dose of the study drug, or no recovery from side effects of such intervention
- •Major surgery within four weeks prior to first dose of the study drug, or no recovery from side effects of such intervention
- •Active infection requiring therapy
- •Concomitant use of systemic steroids at dose of >10 mg of prednisone or its equivalent per day
- •Known or suspected allergy/hypersensitivity to the study drug or any component of the study drug, other monoclonal antibodies, premedication medicines
- •Concurrent participation in another investigational therapeutic clinical trial
- •Pregnant or breast-feeding females
- •Mental or medical conditions that prevent the patient from giving informed consent or participating in the trial
- •Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or the study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for enrollment in this study
- •Note: Other protocol defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Imgatuzumab monotherapy
Experimental
干预措施: Imgatuzumab (Drug)
结局指标
主要结局
Overall Response Rate (ORR) assessed by the Independent Central Review Committee (ICRC) according to the Study Response Criteria
时间窗: Up to 24 months
Proportion of patients achieving Complete Response (CR) or Partial Response (PR) assessed by the ICRC according to the Study Response Criteria
次要结局
- ORR assessed by the ICRC according to the immune Response Evaluation Criteria in Solid Tumors (iRECIST)(Up to 24 months)
- Disease Control Rate (DCR) assessed by the ICRC according to the Study Response Criteria(Up to 24 months)
- ORR assessed by the investigator according to the Study Response Criteria(Up to 24 months)
- DCR assessed by the investigator according to the Study Response Criteria(Up to 24 months)
- Progression-free Survival (PFS) assessed by the ICRC(Up to 24 months)
- Duration of Response (DoR) assessed by the ICRC(Up to 24 months)
- Duration of Stable Disease (DoSD) assessed by the ICRC(Up to 24 months)
- PFS assessed by the investigator(Up to 24 months)
- DoR assessed by the investigator(Up to 24 months)
- DoSD assessed by the investigator(Up to 24 months)
- DCR assessed by the investigator according to the iRECIST(Up to 24 months)
- PFS assessed by the ICRC according to the iRECIST(Up to 24 months)
- DCR assessed by the ICRC according to the iRECIST(Up to 24 months)
- DoR assessed by the ICRC according to the iRECIST(Up to 24 months)
- Area under the curve (AUC)(Up to 24 months)
- Terminal half-life (t[1/2])(Up to 24 months)
- Time to maximum concentration (Tmax)(Up to 24 months)
- Maximum observed concentration (C[max])(Up to 24 months)
- ORR assessed by the investigator according to the iRECIST(Up to 24 months)
- DoR assessed by the investigator according to the iRECIST(Up to 24 months)
- DoSD assessed by the ICRC according to the iRECIST(Up to 24 months)
- DoSD assessed by the investigator according to the iRECIST(Up to 24 months)
- Incidence of Adverse Events(Up to 24 months)
- Frequency of dose interruptions and reductions(Up to 24 months)
- Duration of dose interruptions and reductions(Up to 24 months)
- Concentrations of imgatuzumab-reactive antibodies(Up to 24 months)
- Change in scores of patient-reported outcomes(Up to 24 months)
- PFS assessed by the investigator according to the iRECIST(Up to 24 months)
研究者
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