A Phase 1 Study of Intraperitoneal MCY-M11 Therapy for Women With Platinum Resistant High Grade Serous Adenocarcinoma of the Ovary, Primary Peritoneum, or Fallopian Tube, or Subjects With Peritoneal Mesothelioma With Recurrence After Prior Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Incidence and severity of adverse events as assessed by CTCAE v.5.0
研究概览
简要总结
This is a phase 1 dose escalation study to characterize the feasibility, safety and tolerability of MCY-M11 when administered as an intraperitoneal (IP) infusion for 3 weekly doses for women with platinum resistant high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube, and subjects with peritoneal mesothelioma with recurrence after prior chemotherapy. The study will also assess multiple cycles of treatment and adding preconditioning with cyclophosphamide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able to undergo peripheral blood leukapheresis; have successful placement of an intraperitoneal catheter
- •Be diagnosed with one of the following: metastatic or unresectable high grade serous adenocarcinoma involving the ovary, primary peritoneum, or fallopian tube with peritoneal involvement, not including mixed histologies, OR unresectable epithelioid or biphasic peritoneal mesothelioma
- •Be at least 4 weeks from previous anti-cancer therapy
- •Have a life expectancy of greater than 3 months.
排除标准
- •Females who are pregnant, trying to become pregnant, or breastfeeding
- •Diagnosis of HIV or chronic active Hepatitis B or C
- •Symptomatic or uncontrolled brain metastases requiring current treatment
- •Impaired cardiac function or clinically significant cardiac disease
- •Lack of recovery of prior mild adverse events due to earlier therapies
- •Active infection
- •Another previous or current malignancy within the last 3 years, with exceptions
- •Concomitant chronic use of steroids or NSAIDs
- •Concomitant use of complementary or alternative medication or therapy
- •Autoimmune disease or inflammatory disease within previous 5 years
研究组 & 干预措施
Cohort 1
3-6 subjects will receive a starting dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
干预措施: MCY-M11 (Biological)
Cohort 1
3-6 subjects will receive a starting dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
干预措施: Cyclophosphamide (Drug)
Cohort 2 and 2i
3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 2); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 2i)
干预措施: MCY-M11 (Biological)
Cohort 2 and 2i
3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 2); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 2i)
干预措施: Cyclophosphamide (Drug)
Cohort 3 and 3i
3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 3); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 3i)
干预措施: MCY-M11 (Biological)
Cohort 3 and 3i
3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 3); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 3i)
干预措施: Cyclophosphamide (Drug)
Cohort 4 and 4i
3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 4); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 4i)
干预措施: MCY-M11 (Biological)
Cohort 4 and 4i
3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 4); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 4i)
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Incidence and severity of adverse events as assessed by CTCAE v.5.0
时间窗: 6 weeks
number and severity of adverse events according to NCI CTCAE v.5.0
次要结局
- Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)(from first MCY-M11 dosing to first documented progression, assessed up tp 24 months)
- Response Evaluation Criteria in Solid Tumors (RECIST)(from first MCY-M11 dosing to first documented progression, assessed up to 24 months)