An Open Label Phase 1 Study of SC-006 as a Single Agent and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 29
- 试验地点
- 9
- 主要终点
- Number of participants with dose-limiting toxicities (DLT)
研究概览
简要总结
This is a multicenter, open-label, Phase 1 study of SC-006 given as a single agent and in combination with ABBV-181 in participants with advanced colorectal cancer (CRC), and consists of Part A (single agent SC-006 dose regimen finding), followed by Part B (single agent SC-006 dose expansion), and Part C (SC-006 and ABBV-181 combination escalation and expansion). Part A (dose regimen finding) will involve dose escalation and possible dose interval modification to define the maximum tolerated dose (MTD) and/or recommended Part B dose and schedule. Part B (dose expansion) will enroll additional participants who will be treated with a study drug dose at or below the MTD determined in Part A. Part C is dose escalation of SC-006 and fixed dose of ABBV-181 in combination. Recommended dose cohort of SC-006 with ABBV-181 will be expanded.
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
- •Participants with histologically or cytologically confirmed advanced metastatic or unresectable colorectal cancer (CRC) that is relapsed, refractory, or progressive following at least 2 prior systemic regimens in the metastatic setting.
- •Participants with an Eastern Cooperative Oncology Group (ECOG) of 0 -
- •Participants with adequate hematologic, hepatic, and renal function.
排除标准
- •Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
- •Additional Exclusion Criteria for the SC-006 and ABBV-181 Combination Treatment Regimen:
- •History of inflammatory bowel disease
- •Active autoimmune disease, with exception of psoriasis not requiring systemic treatment, vitiligo, type 1 diabetes mellitus and hypothyroidism
- •History of primary immunodeficiency, allogenic 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
Arm A
SC-006 Dose regimen finding
干预措施: SC-006 (Drug)
Arm B
SC-006 Dose expansion
干预措施: SC-006 (Drug)
Arm C
SC-006 and ABBV-181 Combination escalation and expansion
干预措施: SC-006 (Drug)
Arm C
SC-006 and ABBV-181 Combination escalation and expansion
干预措施: ABBV-181 (Drug)
结局指标
主要结局
Number of participants with dose-limiting toxicities (DLT)
时间窗: Minimum first cycle of dosing (21-day cycles)
DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
次要结局
- Time to Cmax (Tmax) of SC-006(Approximately 1 year)
- Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-006(Approximately 1 year)
- Duration of Clinical Benefit (DOCB)(Approximately 2 years)
- Objective Response Rate (ORR)(Approximately 2 years)
- Terminal half life (T1/2) of SC-006(Approximately 1 year)
- Observed plasma concentrations at trough (Ctrough) of SC-006(Approximately 1 year)
- Clinical Benefit Rate (CBR) defined as CR, PR, or stable disease (SD)(Approximately 2 years)
- Maximum observed serum concentration (Cmax) of SC-006(Approximately 1 year)
- Overall Survival (OS)(Approximately 2 years)
- Progression Free Survival (PFS)(Approximately 2 years)
- Duration of response (DOR)(Approximately 2 years)