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

A Phase 1/2 Study of REGN5093 in Patients With 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

Study Overview

• Status: Active, not recruiting
• Conditions: NSCLC
• Intervention / Treatment: Drug: REGN5093

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Centre Hospitalier Universitaire de Grenoble
  • Montpellier, France, 34295
    • Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve
  • Bretange
    • Rennes, Bretange, France, 35033
      • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
  • New Aquitaine
    • Bordeaux, New Aquitaine, France, 33076
      • Institut Bergonie
  • Normandy
    • Caen, Normandy, France, 14076
      • Centre Francois Baclesse (CFB)
• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 3080
    • Seoul National University Hospital
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
  • Seoul, South Korea, 07061
    • Boramae Medical Center
  • Seoul, South Korea, 06591
    • Seol St. Mary's Hospital
  • Gyeonggi-do
    • Gyeonggi-do, Gyeonggi-do, South Korea, 10408
      • National Cancer Center
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital
    • Suwon, Gyeonggi-do, South Korea, 16499
      • Ajou University Hospital
    • Suwon, Gyeonggi-do, South Korea, 16247
      • The Catholic University Of Korea St. Vincent's Hospital
  • Gyeongsangnam-do
    • Pusan, Gyeongsangnam-do, South Korea, 48108
      • Haeundae Paik Hospital
  • Jeollanam-do
    • Hwasun, Jeollanam-do, South Korea, 58128
      • Chonnam National University Hwasun Hospital
  • Namdong-gu
    • Incheon, Namdong-gu, South Korea, 21565
      • Gachon University Gil Medical Center
  • North Chungcheong
    • Cheongju-si, North Chungcheong, South Korea, 28644
      • Chungbuk National University Hospital
• United States
  • California
    • Orange, California, United States, 92868
      • University of California Irvine Medical Center - Bldg 56, RT81, Rm 241
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center - McKinley Drive
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Harvard Cancer Center Consortium
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh UPMC - Clinical Research Services
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REGN5093; Monotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2)	Drug: REGN5093; Intravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase.; Other Names: davutamig

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with Dose Limiting Toxicities (DLTs)	Phase 1/Dose escalation	Up to 21 days
Incidence and severity of treatment-emergent adverse events (TEAEs)	Phase 1/Dose escalation	Through study completion, an average of 12 years
Incidence and severity of adverse events of special interest (AESIs)	Phase 1/Dose escalation	Through study completion, an average of 12 years
Incidence and severity of serious adverse events (SAEs)	Phase 1/Dose escalation	Through study completion, an average of 12 years
Incidence and severity of grade ≥3 laboratory abnormalities	Phase 1/Dose escalation	Through study completion, an average of 12 years
REGN5093 concentrations in serum over time	Phase 1/Dose escalation	Through study completion, an average of 12 years
Objective response rate (ORR) per RECIST 1.1	Phase 2/Dose expansion	Through study completion, an average of 12 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR per RECIST 1.1	Phase 1/Dose escalation	Through study completion, an average of 12 years
Incidence and severity of TEAEs	Phase 2/Dose expansion	Through study completion, an average of 12 years
Incidence and severity of AESIs	Phase 2/Dose expansion	Through study completion, an average of 12 years
Incidence and severity of SAEs	Phase 2/Dose expansion	Through study completion, an average of 12 years
Incidence and severity of grade ≥3 laboratory abnormalities	Phase 2/Dose expansion	Through study completion, an average of 12 years
REGN5093 Pharmacokinetics (PK)	Phase 2/Dose expansion	Through study completion, an average of 12 years
REGN5093 concentrations in serum over time	Phase 2/Dose expansion	Through study completion, an average of 12 years
Duration of response (DOR) per RECIST 1.1.	Phase 1 and 2	Through study completion, an average of 12 years
Disease control rate (DCR) per RECIST 1.1.	Phase 1 and 2	Through study completion, an average of 12 years
Progression free survival (PFS) per RECIST 1.1.	Phase 1 and 2	Through study completion, an average of 12 years
Overall survival (OS)	Phase 1 and 2	Through study completion, an average of 12 years
Time to response (TTR) per RECIST 1.1	Phase 1 and 2	Through study completion, an average of 12 years
Incidence of anti-drug antibodies (ADA) to REGN5093	Phase 1 and 2	Through study completion, an average of 12 years
Titer of ADA to REGN5093	Phase 1 and 2	Through study completion, an average of 12 years

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2020
• Primary Completion (Estimated): July 6, 2027
• Study Completion (Estimated): July 6, 2027

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): September 4, 2019

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 13, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Unresectable; Metastatic disease; MET (mesenchymal-epithelial transition factor); HGF (Hepatocyte Growth Factor); NSCLC (non-small cell lung cancer); MET-altered advanced
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Deafness, Autosomal Recessive 39
• Other Study ID Numbers: R5093-ONC-1863; 2019 (U.S. NIH Grant/Contract: Chief Medical Office (CMO) Alberta Health Services); 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation); 2019-001908-38 (EudraCT Number); 2023-506248-18-00 (Ctis: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD Sharing Time Frame

When Regeneron has:

• received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
• made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
• has the legal authority to share the data, and
• has ensured the ability to protect participant privacy

• IPD Sharing Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No