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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · September 16, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT04077099). This is a study registration, not published results. Lead sponsor: Regeneron Pharmaceuticals. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 95 participants (ACTUAL). Conditions: NSCLC. Interventions: DRUG: REGN5093. Primary outcome measures: Number of patients with Dose Limiting Toxicities (DLTs) , Up to 21 days; Incidence and severity of treatment-emergent adverse events (TEAEs) , Through study completion, an average of 12 years; Incidence and severity of adverse events of special interest (AESIs) , Through study completion, an average of 12 years; Incidence and severity of serious adverse events (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 concentrations in serum over time , Through study completion, an average of 12 years; Objective response rate (ORR) per RECIST 1.1 , Through study completion, an average of 12 years. Brief summary: 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