A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 95
- 试验地点
- 94
- 主要终点
- Number of patients with Dose Limiting Toxicities (DLTs)
研究概览
简要总结
This study will evaluate REGN5093 for the treatment of Non-Small Cell Lung Cancer (NSCLC) with MET alteration. The main purpose of this study is to determine the safety, tolerability, and effectiveness of REGN5093.
The study has two phases. The main goal of Phase 1 is to determine a safe dose(s) of REGN5093. The main goal of phase 2 of the study is to use the REGN5093 drug dose(s) found in Phase 1 to see how well REGN5093 works to shrink tumors.
The study is looking at several other research questions, including:
- Side effects that may be experienced by people taking REGN5093
- How REGN5093 works in the body
- How much REGN5093 is present in the blood
- To see if REGN5093 works to reduce or delay the progression of cancer
- How long it takes REGN5093 to work in the body
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed advanced NSCLC that is unresectable or metastatic as described in the protocol
- •Willing to provide tumor tissue as described in the protocol
- •Documented presence of MET alteration as described in the protocol.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate organ and bone marrow function as described in the protocol
排除标准
- •Has received treatment with an approved systemic therapy or has participated in any study of an investigational agent or investigational device within 2 weeks as described in the protocol
- •Has not yet recovered from any acute toxicities resulting from prior therapy with certain exceptions as described in the protocol
- •Has received radiation therapy or major surgery within 14 days as described in the protocol
- •Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease or spinal cord compression as defined in the protocol
- •Uncontrolled infection as described in the protocol
- •Note: Other protocol defined Inclusion/Exclusion criteria apply
研究组 & 干预措施
REGN5093
Monotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2)
干预措施: REGN5093 (Drug)
结局指标
主要结局
Number of patients with Dose Limiting Toxicities (DLTs)
时间窗: Up to 21 days
Phase 1/Dose escalation
Incidence and severity of treatment-emergent adverse events (TEAEs)
时间窗: Through study completion, an average of 12 years
Phase 1/Dose escalation
Incidence and severity of adverse events of special interest (AESIs)
时间窗: Through study completion, an average of 12 years
Phase 1/Dose escalation
REGN5093 concentrations in serum over time
时间窗: Through study completion, an average of 12 years
Phase 1/Dose escalation
Incidence and severity of serious adverse events (SAEs)
时间窗: Through study completion, an average of 12 years
Phase 1/Dose escalation
Incidence and severity of grade ≥3 laboratory abnormalities
时间窗: Through study completion, an average of 12 years
Phase 1/Dose escalation
Objective response rate (ORR) per RECIST 1.1
时间窗: Through study completion, an average of 12 years
Phase 2/Dose expansion
次要结局
- ORR per RECIST 1.1(Through study completion, an average of 12 years)
- Incidence and severity of TEAEs(Through study completion, an average of 12 years)
- Incidence and severity of AESIs(Through study completion, an average of 12 years)
- Incidence and severity of SAEs(Through study completion, an average of 12 years)
- Incidence and severity of grade ≥3 laboratory abnormalities(Through study completion, an average of 12 years)
- REGN5093 Pharmacokinetics (PK)(Through study completion, an average of 12 years)
- REGN5093 concentrations in serum over time(Through study completion, an average of 12 years)
- Duration of response (DOR) per RECIST 1.1.(Through study completion, an average of 12 years)
- Disease control rate (DCR) per RECIST 1.1.(Through study completion, an average of 12 years)
- Progression free survival (PFS) per RECIST 1.1.(Through study completion, an average of 12 years)
- Overall survival (OS)(Through study completion, an average of 12 years)
- Time to response (TTR) per RECIST 1.1(Through study completion, an average of 12 years)
- Incidence of anti-drug antibodies (ADA) to REGN5093(Through study completion, an average of 12 years)
- Titer of ADA to REGN5093(Through study completion, an average of 12 years)