NCT02947165已完成1 期
A Phase I/Ib, Open-label, Multi-center Dose Escalation Study of NIS793 in Combination With PDR001 in Adult Patients With Advanced Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Incidence of DLTs, AEs, SAEs and dose reductions / interruptions for NIS793
研究概览
简要总结
To characterize the safety and tolerability of NIS793 as single agent and in combination with PDR001 and to identify recommended doses for future studies.
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
- •Written informed consent must be obtained prior to any screening procedures.
- •Patient (male or female) ≥ 18 years of age.
- •Escalation: Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1 who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
- •Expansion: Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have progressed despite standard therapy following their last prior therapy or are intolerant to standard therapy and fit into one of the following groups: Group 1: NSCLC resistant to anti-PD-1/PD-L1; Group 2: TNBC; Group 3: HCC; Group 4: MSS-CRC; Group 5: pancreatic; Group 6 ccRCC resistant to anti-PD-1/PD-L
- •Resistance to anti-PD-1/PD-L1 therapy is defined as: Documented progressive disease occurring while on/or within 6 months after anti-PD-1 and/or anti-PD-L1 agent (single or combination) received as the last therapy prior to enrollment.
- •ECOG Performance Status ≤
- •Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy. Patient must be willing to undergo a new tumor biopsy at screening, and during therapy on this study. Exceptions may be made on a case by case basis after documented discussion with Novartis.
排除标准
- •History of severe hypersensitivity reactions to study treatment ingredients or other monoclonal antibodies and components of study drug.
- •Patients with active, known or suspected autoimmune disease. Note: Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- •HIV infection.
- •Active HBV or HCV infection.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
NIS793 + PDR001
Experimental
干预措施: PDR001 (Drug)
NIS793
Experimental
干预措施: NIS793 (Drug)
NIS793 + PDR001
Experimental
干预措施: NIS793 (Drug)
结局指标
主要结局
Incidence of DLTs, AEs, SAEs and dose reductions / interruptions for NIS793
时间窗: Up to 90 days after end of treatment
Incidence of DLTs, AEs, SAEs and dose reductions/interruptions for NIS793 in combination with PDR001
时间窗: Up to 150 days after end of treatment
次要结局
- Cmax for NIS793 single agent and NIS793 in combination with PDR001.(48 months)
- Presence of anti-NIS793 and anti-PDR001 antibodies(48 months)
- Best overall response (BOR)(48 months)
- Overall response rate (ORR)(48 months)
- Area under the curve (AUC) for NIS793 single agent and NIS793 in combination with PDR001.(48 months)
- Half life of NIS793 as single agent and in combination with PDR001.(48 months)
- Characterization of tumor infiltrating lymphocytes (TILs) by H&E(48 months)
- Characterization of tumor infiltrating lymphocytes by immunohistochemistry using markers such as CD8 and PD-L1(48 months)
- Disease control rate (DCR)(48 months)
- Concentration of anti-NIS793 and anti-PDR001 antibodies(48 months)
- Progression free survival (PFS)(48 months)
- Duration of response (DOR)(48 months)
- Serum concentration-time profiles of NIS793 single agent and NIS793 in combination with PDR001(48 months)
- Tmax for NIS793 single agent and NIS793 in combination with PDR001.(48 months)
研究者
研究点 (3)
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