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NCT Number: NCT04077099

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

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

Recruiting

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Key information

Conditions

NSCLC Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Deafness, Autosomal Recessive 39 Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centre Georges Francois Leclerc, Dijon, Bourgogne-Franche-Comté, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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
  • Adequate organ and bone marrow function as described in the protocol

Key Exclusion Criteria:

  • 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
  • Uncontrolled infection as described in the protocol

Note: Other protocol defined Inclusion/Exclusion criteria apply

Treatment and study plan

REGN5093

Drug

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

Primary outcomes

  1. Number of patients with Dose Limiting Toxicities (DLTs)

    Time frame: Up to 21 days

    Phase 1/Dose escalation

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

    Time frame: Through study completion, an average of 12 years

    Phase 1/Dose escalation

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

    Time frame: Through study completion, an average of 12 years

    Phase 1/Dose escalation

  4. Incidence and severity of serious adverse events (SAEs)

    Time frame: Through study completion, an average of 12 years

    Phase 1/Dose escalation

  5. Incidence and severity of grade ≥3 laboratory abnormalities

    Time frame: Through study completion, an average of 12 years

    Phase 1/Dose escalation

  6. REGN5093 concentrations in serum over time

    Time frame: Through study completion, an average of 12 years

    Phase 1/Dose escalation

  7. Objective response rate (ORR) per RECIST 1.1

    Time frame: Through study completion, an average of 12 years

    Phase 2/Dose expansion

Secondary outcomes

  1. ORR per RECIST 1.1

    Time frame: Through study completion, an average of 12 years

    Phase 1/Dose escalation

  2. Incidence and severity of TEAEs

    Time frame: Through study completion, an average of 12 years

    Phase 2/Dose expansion

  3. Incidence and severity of AESIs

    Time frame: Through study completion, an average of 12 years

    Phase 2/Dose expansion

  4. Incidence and severity of SAEs

    Time frame: Through study completion, an average of 12 years

    Phase 2/Dose expansion

  5. Incidence and severity of grade ≥3 laboratory abnormalities

    Time frame: Through study completion, an average of 12 years

    Phase 2/Dose expansion

  6. REGN5093 Pharmacokinetics (PK)

    Time frame: Through study completion, an average of 12 years

    Phase 2/Dose expansion

  7. REGN5093 concentrations in serum over time

    Time frame: Through study completion, an average of 12 years

    Phase 2/Dose expansion

  8. Duration of response (DOR) per RECIST 1.1.

    Time frame: Through study completion, an average of 12 years

    Phase 1 and 2

  9. Disease control rate (DCR) per RECIST 1.1.

    Time frame: Through study completion, an average of 12 years

    Phase 1 and 2

  10. Progression free survival (PFS) per RECIST 1.1.

    Time frame: Through study completion, an average of 12 years

    Phase 1 and 2

  11. Overall survival (OS)

    Time frame: Through study completion, an average of 12 years

    Phase 1 and 2

  12. Time to response (TTR) per RECIST 1.1

    Time frame: Through study completion, an average of 12 years

    Phase 1 and 2

  13. Incidence of anti-drug antibodies (ADA) to REGN5093

    Time frame: Through study completion, an average of 12 years

    Phase 1 and 2

  14. Titer of ADA to REGN5093

    Time frame: Through study completion, an average of 12 years

    Phase 1 and 2

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer

Important dates

Study start
2020
Primary completion
2032
Study completion
2032
First posted
Sep 4, 2019
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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