Recruiting
Phase 1
Phase 2

REGN5093

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT04077099

Conditions

NSCLC

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

REGN5093

Study Details

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

Conditions

NSCLC

Study ID

NCT04077099

Start date

Jan 7, 2020

Status verified date

Mar, 2026

Completion date

Apr 22, 2032

Anticipated

Primary completion date

Apr 22, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Group (ECOG) performance status of 0 or 1
5. Adequate organ and bone marrow function as described in the protocol

Key Exclusion Criteria:

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
2. Has not yet recovered from any acute toxicities resulting from prior therapy with certain exceptions as described in the protocol
3. Has received radiation therapy or major surgery within 14 days as described in the protocol
4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease or spinal cord compression as defined in the protocol
5. Uncontrolled infection as described in the protocol

Note: Other protocol defined Inclusion/Exclusion criteria apply

Study Design

Enrollment

231 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: REGN5093

Monotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2)

Interventions

REGN5093

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Moffitt Cancer Center - McKinley Drive

Recruiting

Tampa, Florida, United States, 33612

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Jun 17, 2026

Last verified

Mar, 2026

Keywords

  • MET (mesenchymal-epithelial transition factor)
  • HGF (Hepatocyte Growth Factor)
  • NSCLC (non-small cell lung cancer)
  • MET-altered advanced
  • Unresectable
  • Metastatic disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-06-17.