Recently added Catalysts

REGN5093

Phase 1

NSCLC | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Jun 17, 2026

Target and mechanism

Molecular targetMET

Target classProtein

ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED

Total Trials1

Total Enrollment231

FDA Designations

No designations recorded

Clinical trial landscape

REGN5093 · 1 trial · 1 indication

Phase 1 1

NCT04077099A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung CancerNSCLC

RECRUITING231 Analytics

PHASE1RECRUITING

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

NSCLC

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Study Endpoints

Primary Endpoints

Number of patients with Dose Limiting Toxicities (DLTs)

Up to 21 days

Phase 1/Dose escalation

Incidence and severity of treatment-emergent adverse events (TEAEs)

Through study completion, an average of 12 years

Phase 1/Dose escalation

Incidence and severity of adverse events of special interest (AESIs)

Through study completion, an average of 12 years

Phase 1/Dose escalation

Incidence and severity of serious adverse events (SAEs)

Through study completion, an average of 12 years

Phase 1/Dose escalation

Incidence and severity of grade ≥3 laboratory abnormalities

Through study completion, an average of 12 years

Phase 1/Dose escalation

REGN5093 concentrations in serum over time

Through study completion, an average of 12 years

Phase 1/Dose escalation

Objective response rate (ORR) per RECIST 1.1

Through study completion, an average of 12 years

Phase 2/Dose expansion

Secondary Endpoints

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

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Study Design & Arms

AllocationNA

MaskingNONE

ModelSINGLE_GROUP

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
REGN5093	EXPERIMENTAL	Monotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2)

Interventions

Name	Type	Description
REGN5093	DRUG	Intravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase.

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Eligibility Criteria

Age Range18 Years to N/A

SexALL

Healthy VolunteersNo

Study Sites40

Key Inclusion Criteria: 1. Histologically confirmed advanced NSCLC that is unresectable or metastatic as described in the protocol 2. Willing to provide tumor tissue as described in the protocol 3. Documented presence of MET alteration as described in the protocol. 4. Eastern Cooperative Oncology G...

Countries:United StatesFranceSouth Korea

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Recent Changes (Last 90 Days)

LOWJun 18, 2026NCT04077099lastUpdatePostDate: changed

LOWJun 18, 2026NCT04077099lastUpdatePostDate: changed

LOWJun 18, 2026NCT04077099lastUpdatePostDate: changed

LOWJun 18, 2026NCT04077099lastUpdatePostDate: changed

Frequently asked questions about REGN5093

What is REGN5093 used for in NSCLC?

REGN5093 is an investigational small molecule being studied for the treatment of advanced non-small cell lung cancer (NSCLC) in adult patients with MET-altered tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does REGN5093 target?

REGN5093 targets MET, a protein involved in cell growth and survival. By targeting MET, the drug aims to interfere with signaling pathways that may drive tumor growth in MET-altered advanced non-small cell lung cancer.

Who makes REGN5093?

REGN5093 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol REGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with MET-altered advanced non-small cell lung cancer.

What phase is REGN5093 in?

REGN5093 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and preliminary activity.

What clinical trials is REGN5093 in?

REGN5093 is being evaluated in a Phase 1 clinical trial with the identifier NCT04077099. This open-label, uncontrolled study is recruiting adult patients with MET-altered advanced non-small cell lung cancer in the United States, France, and South Korea, with a target enrollment of 231 participants.

Is REGN5093 the same as any other drug?

REGN5093 is a distinct investigational compound developed by Regeneron Pharmaceuticals. No alternative names for this drug have been reported in the available clinical trial information.