An Open-Label, Single-Arm, Phase II Safety and Tolerability Study of Catumaxomab (Anti-EpCAM x Anti-CD3) in Women With Advanced Epithelial Ovarian Cancer After a Complete Response to Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 12
- 主要终点
- Number of Participants Who Completed a 4-dose Series of Catumaxomab Infusions (Defined as 10-20-50-150 Micrograms) Within 21 Days
研究概览
简要总结
The purpose of this study is to determine whether the investigational drug catumaxomab delivered in the planned treatment schedule is a safe and effective treatment for women with advanced ovarian cancer who experience a complete response to chemotherapy.
详细描述
A multi-center, phase II study of catumaxomab in ovarian cancer patients who experience a complete response to chemotherapy. Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter or port. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 3-4 days. Each patient will participate in this study for up to 4 months (includes the baseline screening period, 11 to 21 days treatment period, and up to 90 days/3 months follow-up), with post-study follow-up every 3 months for 2 years.
Catumaxomab is a trifunctional antibody targeting epithelial cell adhesion molecule (EpCAM) on tumor cells and CD3 (cluster of differentiation 3) on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent form before any protocol-specific screening procedures
- •Histologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) stage IIb - IV
- •Optimal or sub-optimal cytoreductive surgery
- •Clinical complete response to platinum and taxane-based therapy consisting of at least four cycles, based on computed tomography (CT) scan and a CA-125 (cancer antigen 125) level below 35 U/mL
- •Age ≥18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Last dose of platinum and taxane-based therapy completed within 6 weeks prior to the start of catumaxomab treatment
- •Negative serum pregnancy test result at screening in women of childbearing potential (applies to patients without documented menopause or sterility)
- •Willingness of patients of childbearing potential to use an effective contraceptive method (i.e. oral contraceptive, cervical cap, diaphragm with spermicide, condom with spermicide, or intrauterine device) during the study and for at least 6 months after the last infusion
排除标准
- •Acute or chronic systemic infection
- •Exposure to chemotherapy, radiotherapy, immunotherapy or investigational anti-cancer therapy within 6 weeks of first dose of catumaxomab other than last regimen of platinum and taxane chemotherapy as outlined in protocol
- •Known human immunodeficiency virus (HIV) infection
- •Previous treatment with non-humanized murine (rat or mouse) monoclonal antibodies (mAb)
- •Inadequate renal function (creatinine > 1.5 x upper limit of normal [ULN])
- •Inadequate hepatic function:
- •Alanine aminotransferase (ALT) > 2.5 x ULN or
- •Aspartate aminotransferase (AST) > 2.5 x ULN or
- •Bilirubin > 1.5 x ULN
- •Platelets < 100,000 cells/mm^3
- •Absolute neutrophil count (ANC) < 1,500 cells/mm^3
- •History of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia within the last 6 months
- •No other malignancy within the past 5 years except non-melanoma skin cancer or carcinoma in situ of the cervix if adequately treated
- •No history of brain metastases
- •Any further condition or disease that would, in the opinion of the Investigator, expose the patient to undue risk
研究组 & 干预措施
catumaxomab
干预措施: catumaxomab (Drug)
结局指标
主要结局
Number of Participants Who Completed a 4-dose Series of Catumaxomab Infusions (Defined as 10-20-50-150 Micrograms) Within 21 Days
时间窗: 21 days
次要结局
- Number of Participants With Negative (Undetectable) Humoral Immune Responses to Catumaxomab Therapy(2 months)
- Number of Participants With no Residual Disease Prior to Catumaxomab Treatment Via 2nd-look Laparoscopy or Laparotomy (These Procedures Are Optional)(Baseline)
- Median Time of Progression-free Survival in Weeks (Post-study for 24 Months)(2 years)
- Number of Participants Who Survived (Post-study at 24 Month Visit)(2 years)
- Number of Participants With no Residual Disease at 3 Months After Catumaxomab Treatment Via 3rd-look Laparoscopy or Laparotomy (These Procedures Are Optional)(3 months)