A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer

Официальное название

A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer

Обзор

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

Вмешательства

• Препарат REGN5093
  Intravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase.

Первичные конечные точки

• Number of patients with Dose Limiting Toxicities (DLTs) [Срок оценки: Up to 21 days]
• Incidence and severity of treatment-emergent adverse events (TEAEs) [Срок оценки: Through study completion, an average of 12 years]
• Incidence and severity of adverse events of special interest (AESIs) [Срок оценки: Through study completion, an average of 12 years]
• Incidence and severity of serious adverse events (SAEs) [Срок оценки: Through study completion, an average of 12 years]
• Incidence and severity of grade ≥3 laboratory abnormalities [Срок оценки: Through study completion, an average of 12 years]
• REGN5093 concentrations in serum over time [Срок оценки: Through study completion, an average of 12 years]
• Objective response rate (ORR) per RECIST 1.1 [Срок оценки: Through study completion, an average of 12 years]

Вторичные конечные точки (12)

• ORR per RECIST 1.1 [Срок оценки: Through study completion, an average of 12 years]
• Incidence and severity of TEAEs [Срок оценки: Through study completion, an average of 12 years]
• Incidence and severity of AESIs [Срок оценки: Through study completion, an average of 12 years]
• Incidence and severity of SAEs [Срок оценки: Through study completion, an average of 12 years]
• Incidence and severity of grade ≥3 laboratory abnormalities [Срок оценки: Through study completion, an average of 12 years]
• REGN5093 Pharmacokinetics (PK) [Срок оценки: Through study completion, an average of 12 years]
• REGN5093 concentrations in serum over time [Срок оценки: Through study completion, an average of 12 years]
• Duration of response (DOR) per RECIST 1.1. [Срок оценки: Through study completion, an average of 12 years]
• Disease control rate (DCR) per RECIST 1.1. [Срок оценки: Through study completion, an average of 12 years]
• Progression free survival (PFS) per RECIST 1.1. [Срок оценки: Through study completion, an average of 12 years]
• Overall survival (OS) [Срок оценки: Through study completion, an average of 12 years]
• Time to response (TTR) per RECIST 1.1 [Срок оценки: Through study completion, an average of 12 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 18 центров

• University of Alabama at Birmingham — Birmingham
• University of California Irvine Medical Center - Bldg 56, RT81, Rm 241 — Orange
• Georgetown University Medical Center — Washington D.C.
• Moffitt Cancer Center - McKinley Drive — Tampa
• University of Kentucky, Markey Cancer Center Clinical Research Organization — Lexington
• DNU_Massachusetts General Hospital_DNU — Boston
• Dana Farber Harvard Cancer Center Consortium — Boston
• Henry Ford Health System — Detroit
• … и ещё 10 центров

South Korea · 16 центров

• National Cancer Center — Gyeonggi-do
• Seoul National University Bundang Hospital — Seongnam-si
• The Catholic University Of Korea St. Vincent's Hospital — Suwon
• Ajou University Hospital — Suwon
• Haeundae Paik Hospital — Pusan
• Chonnam National University Hwasun Hospital — Hwasun
• Gachon University Gil Medical Center — Incheon
• Chungbuk National University Hospital — Cheongju-si
• … и ещё 8 центров

Франция · 6 центров

• Centre Georges Francois Leclerc — Dijon
• Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou — Rennes
• Institut Bergonie — Bordeaux
• Centre Francois Baclesse (CFB) — Caen
• Centre Hospitalier Universitaire de Grenoble — Grenoble
• Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve — Montpellier

Идентификаторы

NCT: NCT04077099 · R5093-ONC-1863 · 2019-001908-38 · 2023-506248-18-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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