A Phase II Clinical Study of the Treatment of Disitamab Vedotin（RC48) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Expressing HER2
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 63
- 主要终点
- Object Response Rate, ORR
研究概览
简要总结
This is a phase 2 clinical study,to explore the efficacy and safety of Disitamab Vedotin in patients with locally advanced or metastatic pancreatic cancer expressing HER2.
详细描述
63 patients with locally advanced or metastatic pancreatic cancer will participate in this study. HER2 expression in locally advanced or metastatic pancreatic cancer patients is defined as the expression of HER2 in tumor tissues detected by immunohistochemistry (IHC) as IHC 1+, 2+, or 3+. The arm 1 recruits 43 patients and the arm 2 recruits 20 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age: 18 (inclusive) or above, regardless of gender.
- •histologically or cytologically confirmed patients with locally advanced or metastatic pancreatic cancer who cannot undergo radical surgery
- •HER2 expressing(Immunohistochemical IHC 1+,2+ or 3+)
- •Number of treatment lines: Cohort 1: Prior first-line gemcitabine-free regimen or intolerant to gemcitabine-containing regimen; Cohort 2: Previous treatment with second-line standard or intolerance
- •Patients who have previously received neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy or chemoradiotherapy for the purpose of curing non-metastatic disease must have a disease-free interval of 6 months from the last chemotherapy and/or radiotherapy to the random date
- •There is at least one measurable lesion that meets the definition of the RECIST 1.1 standard at baseline.
- •ECOG fitness status score: 0 or 1 point.
- •Estimated survival time ≥ 3 months.
- •Adequate organ function.
- •Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
- •Voluntary agreement to provide written informed consent.
排除标准
- •Central nervous system metastasis or meningeal metastasis with clinical symptoms.
- •Have a history of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- •Active hepatitis B (hepatitis B virus titer>1000 copies/ml or 200 IU/ml); Hepatitis C virus and syphilis infection.
- •Have undergone major organ surgery (excluding puncture biopsy) or have experienced significant trauma within 3 weeks before the first use of the study drug.
- •Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.
- •Strong inducers and inhibitors of P-gp, a strong or moderate inducer of CYP3A4, used within 14 days prior to the first use of the study drug
研究组 & 干预措施
Disitamab Vedotin combined with Gemcitabine，2L
Disitamab Vedotin 2.5 mg/kg，iv，Q3W; Gemcitabine 1g/m2，iv，d1, d8 Q3W; Disitamab Vedotin+Gemcitabine is used as second-line treatment for HER2-expressive patients who have failed first-line gemcitabine-free regimen or are intolerant to gemcitabine-containing regimen.
干预措施: Disitamab Vedotin (Drug)
Disitamab Vedotin combined with Gemcitabine，2L
Disitamab Vedotin 2.5 mg/kg，iv，Q3W; Gemcitabine 1g/m2，iv，d1, d8 Q3W; Disitamab Vedotin+Gemcitabine is used as second-line treatment for HER2-expressive patients who have failed first-line gemcitabine-free regimen or are intolerant to gemcitabine-containing regimen.
干预措施: Gemcitabine (Drug)
Disitamab Vedotin，3L
Disitamab Vedotin 2.5 mg/kg，iv，Q3W; Disitamab Vedotin in HER2-expressive patients who have failed at second-line standard treatment or are intolerant
干预措施: Disitamab Vedotin (Drug)
结局指标
主要结局
Object Response Rate, ORR
时间窗: up to 12 months
Defined as the percentage of participants with a complete response (CR) or partial response (PR)
次要结局
- Disease Control Rate, DCR(up to 12 months)
- Progress Free Survival, PFS(up to 12 months)
- Over Survival, OS(up to 12 months)
- Adverse Events (AE)(up to 12 months)
研究者
Dong sheng Zhang
PHD
Sun Yat-sen University