NCT02539719终止1 期
A Phase 1a/1b Dose Escalation and Expansion Study of SC-003 as a Single-Agent and in Combination With ABBV-181 in Subjects With Platinum-Resistant/ Refractory Ovarian Cancer
Stemcentrx0 个研究点目标入组 74 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 74
- 主要终点
- Adverse Events
研究概览
简要总结
This is a Phase 1a/1b study of SC-003 as a single agent and in combination with ABBV-181 in patients with platinum-resistant/refractory ovarian cancer. SC-003 is an antibody-drug conjugate (ADC) comprised of a monoclonal antibody linked to a potent chemotherapy. ABBV-181 is a humanized, recombinant, mAb that binds to cell surface expressed programmed cell death 1 (PD-1).
详细描述
Phase 1a is a dose escalation study in patients with histologically/cytologically confirmed ovarian cancer that are platinum-resistant or refractory. Phase 1b is an expansion study where patients will be enrolled and treated at recommended dose and schedule based on the Phase 1a.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed ovarian epithelial cancer
- •Evidence of progressive disease (PD) on or within 6 months of a platinum (cisplatin or carboplatin) regimen: at least 1 prior regimen must have contained a platinum-taxane combination
- •Measurable disease as defined by RECIST 1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Fresh or archived tumor tissue sample available for target expression analysis. [Phase 1b only: Subjects' tumor tissue must test positive for target expression.]
- •Adequate hematologic and organ function as confirmed by laboratory values
- •At least 3 weeks between last systemic chemotherapy and planned start of study treatment (4 weeks for prior investigational drugs, immunotherapy, radiotherapy, or biologics) for ovarian cancer
- •At least 3 weeks between major surgery and planned start of study treatment; major incisions must have healed
排除标准
- •History of prior malignancy, with the exception of the following: malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening and felt to be at low risk for recurrence by treating physician; or adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer; or adequately treated cervical carcinoma in situ without current evidence of disease.
- •Uncontrolled infection requiring systemic antibiotics/antivirals/antifungals
- •Evidence of complete or partial bowel obstruction
- •Patients requiring IV hydration or parenteral nutrition
- •Positive pregnancy test in females of child-bearing potential or pregnant or currently breastfeeding
- •Known hypersensitivity to any component of study drug including potential subjects with a history of major immunologic reaction to any IgG-containing agent
- •Inability to tolerate premedication with dexamethasone
- •Uncontrolled cardiac disease, or myocardial infarction within the last 12 months, or left ventricular ejection fraction (LVEF) < 50%, or QTcF interval > 470 msec
- •Class II, III or IV heart failure as defined by the NYHA functional class system
- •Positive serology for hepatitis B or C, or known human immunodeficiency virus infection (HIV)
- •Previous treatment with a pyrrolobenzodiazepine (PBD)-based drug
- •Additional exclusion criteria for the SC-003 and ABBV-181 combination treatment regimen:
- •History of inflammatory bowel disease
- •Active autoimmune disease, with exceptions of psoriasis not requiring systemic treatment, vitiligo, type 1 diabetes mellitus and hypothyroidism
- •History of primary immunodeficiency, allogeneic bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis
- •History of immune-mediated pneumonitis
- •Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment
研究组 & 干预措施
SC-003
Experimental
Phase 1a (Escalation) - IV infusion Phase 1b (Expansion) - IV infusion
干预措施: SC-003 (Drug)
SC-003 in combination with ABBV-181
Experimental
Phase 1a (Escalation) - IV infusion of SC-003 followed by IV infusion of ABBV-181 Phase 1b (Expansion) - IV Infusion of SC-003 followed by IV infusion of ABBV-181
干预措施: SC-003 in combination with ABBV-181 (Drug)
结局指标
主要结局
Adverse Events
时间窗: 18 months (Phase 1a/1b)
次要结局
- Pharmacokinetics of SC-003: Ctrough (concentration at trough)(Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min)
- Pharmacokinetics of SC-003: CL (clearance)(Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min)
- Pharmacokinetics of SC-003: Tmax (time of maximum concentration)(Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min)
- Pharmacokinetics of SC-003: T1/2 (terminal half life)(Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min)
- Overall Response Rate(18 months (Phase 1a/1b))
- Pharmacokinetics of SC-003: AUC (area under the curve)(Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min))
- Pharmacokinetics of SC-003: Cmax (maximum concentration)(Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min)
- Pharmacokinetics of SC-003: Vss (volume of distribution at steady state)(Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min)
研究者
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