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
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
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
Single group
REGN5093
DrugIntravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase.
Number of patients with Dose Limiting Toxicities (DLTs)
Phase 1/Dose escalation
Incidence and severity of treatment-emergent adverse events (TEAEs)
Phase 1/Dose escalation
Incidence and severity of adverse events of special interest (AESIs)
Phase 1/Dose escalation
Incidence and severity of serious adverse events (SAEs)
Phase 1/Dose escalation
ORR per RECIST 1.1
Phase 1/Dose escalation
Incidence and severity of TEAEs
Phase 2/Dose expansion
Incidence and severity of AESIs
Phase 2/Dose expansion
Incidence and severity of SAEs
Phase 2/Dose expansion
Click on the lead sponsor to view all of their trials.
