A PHASE 1/2 STUDY OF REGN5093 IN PATIENTS WITH MET-ALTERED ADVANCED NON-SMALL CELL LUNG CANCER
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 6
- 主要终点
- Phase 1: Number of patients with Dose Limiting Toxicities
研究概览
简要总结
Phase 1: To assess the safety, tolerability, and pharmacokinetics (PK) of REGN5093 for determination of the maximum tolerated dose (MTD) and/or definition of the recommended phase 2 dose (RP2D) of REGN5093 in patients with MET-altered non-small cell lung cancer (NSCLC) Phase 2: To assess preliminary anti-tumor activity of REGN5093 as measured by the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
研究设计
- 研究类型
- Interventional
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
- •Histologically confirmed NSCLC that is at advanced stage. Advanced is defined as unresectable or metastatic disease. Patients must have exhausted all approved available therapies appropriate for the patient.
- •Has available archival tumor tissue, unless discussed with the medical monitor.
- •Willing to provide tumor tissue from newly obtained biopsy. Newly obtained biopsies at screening are required unless medically contra-indicated and discussed with the medical monitor. For patients in expansion cohorts, biopsies should be taken from tumor site which has not been irradiated previously and is not the only measurable target lesion.
- •Previously documented presence of MET alterations: either MET-exon14 gene mutation and/or MET gene amplification, and/or elevated MET protein expression, as defined in the protocol.
- •Note: Other protocol defined Inclusion criteria apply.
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 or 5 half-lives of the prior treatment whichever is shorter with a minimum of 7 days from the first dose of study therapy
- •Has not yet recovered (i.e. grade ≤1 or baseline) from any acute toxicities resulting from prior therapy except as described in the protocol
- •Has received radiation therapy or major surgery within 14 days of first administration of study drug or has not recovered (i.e. grade ≤1 or baseline) from AEs, except for laboratory changes as described in the protocol and patients with grade ≤2 neuropathy
- •For expansion cohorts only: prior treatment with MET-targeted biologic therapy (function-blocking antibodies or ADCs)
- •For expansion cohorts only (except cohort 1A) prior treatment with any MET-targeted agent including small molecule tyrosine kinase inhibitors eg, crizotinib, capmatinib, tepotinib, as defined in the protocol
- •Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease or spinal cord compression as defined in the protocol
- •Note: Other protocol defined Exclusion criteria apply.
结局指标
主要结局
Phase 1: Number of patients with Dose Limiting Toxicities
Phase 1: Number of patients with Dose Limiting Toxicities
Phase 1: Incidence and severity of treatment-emergent adverse events
Phase 1: Incidence and severity of treatment-emergent adverse events
Phase 1: Incidence and severity of adverse events of special interest (AESIs)
Phase 1: Incidence and severity of adverse events of special interest (AESIs)
Phase 1: Incidence and severity of serious adverse events (SAEs)
Phase 1: Incidence and severity of serious adverse events (SAEs)
Phase 1: Incidence and severity of grade ≥3 laboratory abnormalities
Phase 1: Incidence and severity of grade ≥3 laboratory abnormalities
Phase 1: REGN5093 concentrations in serum over time
Phase 1: REGN5093 concentrations in serum over time
Phase 2: Objective response rate (ORR) per RECIST 1.1
Phase 2: Objective response rate (ORR) per RECIST 1.1
次要结局
- Phase 1: ORR per RECIST 1.1
- Phase 2: Incidence and severity of TEAEs
- Phase 2: Incidence and severity of AESIs
- Phase 2: Incidence and severity of SAEs
- Phase 2: Incidence and severity of grade ≥3 laboratory abnormalities
- Phase 2: REGN5093 Pharmacokinetics (PK)
- Phase 2: REGN5093 concentrations in serum over time
- Phase 1 and 2: Duration of response (DOR) per RECIST 1.1.
- Phase 1 and 2: Disease control rate (DCR) per RECIST 1.1.
- Phase 1 and 2: Progression free survival (PFS) per RECIST 1.1.
- Phase 1 and 2: Overall survival (OS)
- Phase 1 and 2: Immunogenicity as measured by Anti-drug antibodies (ADA) to REGN5093
研究者
Medical Affairs
Scientific
Regeneron Pharmaceuticals Inc.