A Phase I, Open-Label, Dose Finding Study of CC-90002, a Monoclonal Antibody Directed Against CD47, in Subjects With Advanced Solid and Hematologic Cancers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 60
- 试验地点
- 13
- 主要终点
- Dose-Limiting Toxicity (DLT)
研究概览
简要总结
CC-90002-ST -001 is an open-label, Phase 1, dose escalation clinical study in subjects with advanced, refractory solid and hematologic cancers.
详细描述
CC-90002-ST-001 is an open-label, Phase 1, dose escalation, first in human (FIH) clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with advanced, refractory solid and hematologic cancers.
The study will be conducted in two parts. Part A dose escalation phase will explore escalating dose cohorts of the study drug CC-90002.
Part B dose escalation will explore escalating doses of CC-90002 in combination with rituximab in subjects with CD20-positive NHL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Men and women, 18 years or older, with advanced, relapsed or refractory solid tumors, Multiple Myeloma (MM) or non-Hodgkin's lymphoma (NHL) in Part A. In Part B, relapsed and/or refractory CD20-positive NHL subjects only.
- •At least one site of measurable disease in subjects with solid tumors and NHL.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or
- •Subjects must have adequate hematopoietic, liver, renal and coagulation function as assessed by specific laboratory criteria.
- •Females and males must agree to contraceptive methods and avoid conceiving throughout the study, and for up to 8 weeks following the last dose of CC-
- •If participating in Part B, females of child bearing potential should continue to use effective contraceptive methods for 12 months following treatment with rituximab
排除标准
- •High grade lymphomas (Burkitts or lymphoblastic), plasma cell leukemia.
- •High grade, rapidly proliferative solid tumors (eg, small cell lung cancer, germ cell tumors, neuroblastoma) with extensive tumor burden.
- •Symptomatic central nervous system involvement.
- •Impaired cardiac function or clinically significant cardiac disease.
- •Prior Red blood cell (RBC) transfusion < 3 months prior to starting CC-90002 (Part A only).
- •Prior autologous stem cell transplant ≤ 3 months prior to starting CC-
- •Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-
- •Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting CC-90002, whichever is shorter.
- •Major surgery ≤ 2 weeks prior to starting CC-
- •Pregnant or nursing females.
- •Known HIV infection.
- •Known chronic, active hepatitis B or C (HBV/HCV) infection.
- •Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
- •History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
- •History of concurrent second cancers requiring active, ongoing systemic treatment.
- •concurrent second cancers requiring active, ongoing systemic treatment.
研究组 & 干预措施
Part A: CC-90002
CC-90002 will be given by intravenous (IV) infusion on a 28 day cycle
干预措施: CC-90002 (Drug)
Part B: CC-90002 with Rituximab
CC-90002 in combination with Rituximab will be given by intravenous (IV) infusion on a 28 day cycle in subjects with CD20-positive NHL
干预措施: CC-90002 (Drug)
Part B: CC-90002 with Rituximab
CC-90002 in combination with Rituximab will be given by intravenous (IV) infusion on a 28 day cycle in subjects with CD20-positive NHL
干预措施: Rituximab (Drug)
结局指标
主要结局
Dose-Limiting Toxicity (DLT)
时间窗: Up to 18 months
Number of participants with a DLT
Maximum Tolerated Dose (MTD) - Part A
时间窗: Up to 18 months
Dose that is the last dose level below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during Cycle 1.
Non-Tolerated Dose (NTD) - Part B
时间窗: Up to 24 months
Dose at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in Cycle 1.
Maximum Tolerated Dose (MTD) - Part B
时间窗: Up to 24 months
Dose that is the last dose level below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during Cycle 1.
Non-Tolerated Dose (NTD) - Part A
时间窗: Up to 18 months
Dose at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in Cycle 1.
次要结局
- Pharmacokinetics - AUC(Cycle 1 and beyond; and after discontinuation)
- Progression-free survival- Part B(Up to 2 years)
- Antitumor efficacy(Up to 36 months)
- Pharmacokinetics - tmax(Cycle 1 and beyond; and after discontinuation)
- Pharmacokinetics - T1/2(Cycle 1 and beyond; and after discontinuation)
- Pharmacokinetics - CL(Cycle 1 and beyond; and after discontinuation)
- Pharmacokinetics - Vmax(Cycle 1 and beyond; and after discontinuation)
- Overall Survival - Part B(Up to 2 years)
- Pharmacokinetics - Cmax(Cycle 1 and beyond; and after discontinuation)
- Anti-Drug Antibodies (ADAs)(Cycle 1 and beyond; and after discontinuation)