A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects with Methylthioadenosine Phosphorylase (MTAP)-deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 107
- 试验地点
- 64
- 主要终点
- Objective response (OR) (complete response [CR] and partial response [PR]) measured by computed tomography (CT) or Magnetic resonance imaging (MRI) and assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
研究概览
简要总结
To characterize safety and efficacy of 2 dose levels of AMG 193 by investigator (Part 1 only) To evaluate AMG 193 monotherapy efficacy by Blinded Independent Central Review (BICR) (Part 1 and Part 2)
研究设计
- 分配方式
- Non Randomized
- 主要目的
- Part 2 – dose expansion
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP in the tumor tissue) non-small cell lung cancer.
- •Participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease.
- •Either an archival tissue sample or an archival block must be available.
- •Life expectancy of greater than 3 months, in the opinion of the investigator.
- •Participants who have had brain metastases and have been appropriately treated with radiation therapy or surgery ending at least 14 days before study day 1 are eligible.
- •Participants with untreated asymptomatic brain metastases smaller or equal to 2 cm in size (per lesion if more than one) and not requiring corticosteroid treatment are eligible.
排除标准
- •Tumors harboring the following mutations amenable to targeted therapies: epidermal growth factor receptor (EGFR), ALK receptor tyrosine kinase (ALK), ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), MET proto-oncogene (MET), B-Raf proto-oncogene (BRAF), RET proto-oncogene (RET), Human epidermal growth factor receptor 2 (HER2/ERBB2), KRAS proto-oncogene G12C (KRAS G12C).
- •Major surgery within 28 days of study day
- •Untreated symptomatic central nervous system (CNS) metastatic disease regardless of size or asymptomatic brain metastases greater than 2 cm per lesion.
研究组 & 干预措施
AMG 193
干预措施: AMG 193 (Drug)
结局指标
主要结局
Objective response (OR) (complete response [CR] and partial response [PR]) measured by computed tomography (CT) or Magnetic resonance imaging (MRI) and assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Objective response (OR) (complete response [CR] and partial response [PR]) measured by computed tomography (CT) or Magnetic resonance imaging (MRI) and assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Incidence of treatment-emergent adverse events (TEAEs), grade ≥ 3 TEAEs, Serious Adverse Events (SAEs), and Events of Interest (EOIs)
Incidence of treatment-emergent adverse events (TEAEs), grade ≥ 3 TEAEs, Serious Adverse Events (SAEs), and Events of Interest (EOIs)
Pharmacokinetic (PK) parameters of AMG 193 including, but not limited to, maximum concentration (Cmax), time to maximum concentration (Tmax), and area under the concentration-time curve (AUC)
Pharmacokinetic (PK) parameters of AMG 193 including, but not limited to, maximum concentration (Cmax), time to maximum concentration (Tmax), and area under the concentration-time curve (AUC)
OR (CR and PR) per RECIST 1.1
OR (CR and PR) per RECIST 1.1
次要结局
- Incidence and severity of TEAEs, grade ≥ 3 TEAEs, SAEs, and EOIs
- PK parameters of AMG 193 including, but not limited to Cmax, Tmax, and AUC
- Overall survival (OS)
- Disease control (DC), Duration of response (DOR), Time to response (TTR), Progression free survival (PFS)
- OR (CR and PR), DC, DOR, TTR, PFS
- Changes in cancer-specific symptoms, treatment-related symptom and overall health status using subject-reported outcome instruments: o EORTC QLQ-C30 o QLQ LC13 o EQ-5D-5L o PRO-CTCAE o GP5 of FACT-G
研究者
Medical Information
Scientific
Amgen Inc.