A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety and Anti-tumor Activity of GEN1042 in Subjects With Malignant Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Genmab A/S
- 入组人数
- 270
- 试验地点
- 29
- 主要终点
- For dose escalation and safety run-in: • Dose-limiting toxicity (DLT) For dose expansion as monotherapy and in combination: • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment
研究概览
简要总结
For dose escalation and safety run-in: • To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of GEN1042 administered alone or in combination with pembrolizumab with or without chemotherapy
For dose expansion as monotherapy and in combination: • To evaluate the anti-tumor activity of GEN1042 administered as monotherapy and in combination with pembrolizumab with or without chemotherapy
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Monotherapy • Combination Therapy As defined in the protocol section Inclusion criteria
排除标准
- •Monotherapy • Combination Therapy As defined in the protocol section exclusion criteria
结局指标
主要结局
For dose escalation and safety run-in: • Dose-limiting toxicity (DLT) For dose expansion as monotherapy and in combination: • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment
For dose escalation and safety run-in: • Dose-limiting toxicity (DLT) For dose expansion as monotherapy and in combination: • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment
次要结局
- - Adverse events (AEs) and safety laboratory parameters - ORR per RECIST 1.1 by investigator assessment (for dose escalation only) • Duration of response (DOR) per RECIST 1.1 by investigator assessment • Disease Control Rate (DCR) per RECIST 1.1 by investigator assessment • Progression-free survival (PFS) per RECIST 1.1 by investigator assessment • OS - PK parameters and anti-drug antibodies (ADAs)
研究者
Genmab Trial Information
Scientific
Genmab A/S