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REGN5093

Phase 1

NSCLC | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Mar 18, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment231
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04077099A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung CancerPHASE1 RECRUITING 231 — — Jan 7, 2020Apr 22, 2032Mar 18, 202640 United States, France +1
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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
ArmTypeDescription
REGN5093EXPERIMENTALMonotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2)
Interventions
NameTypeDescription
REGN5093DRUGIntravenous (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 — 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)
LOWMay 26, 2026NCT04077099primaryCompletionDate: changed
LOWMay 24, 2026NCT04077099studyFirstPostDate: changed