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REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT04077099
Recruitment Status : Recruiting
First Posted : September 4, 2019
Last Update Posted : June 16, 2021
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The primary objective of the dose escalation (phase 1) part of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of REGN5093 for determination of the maximum tolerated dose (MTD) and/or definition of the recommended phase 2 dose (RP2D) of REGN5093 in patients with MET-altered Non-small cell lung cancer (NSCLC).

The primary objective of the dose expansion (phase 2) part of the study is to assess preliminary anti-tumor activity of REGN5093 as measured by the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)


Condition or disease Intervention/treatment Phase
NSCLC Drug: REGN5093 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer
Actual Study Start Date : January 7, 2020
Estimated Primary Completion Date : November 3, 2023
Estimated Study Completion Date : November 3, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Number of patients with Dose Limiting Toxicities [ Time Frame: Up to 21 days ]
    Phase 1/Dose escalation

  2. Incidence and severity of treatment-emergent adverse events [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1/Dose escalation

  3. Incidence and severity of adverse events of special interest (AESIs) [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1/Dose escalation

  4. Incidence and severity of serious adverse events (SAEs) [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1/Dose escalation

  5. Incidence and severity of grade ≥3 laboratory abnormalities [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1/Dose escalation

  6. REGN5093 concentrations in serum over time [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1/Dose escalation

  7. Objective response rate (ORR) per RECIST 1.1 [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion


Secondary Outcome Measures :
  1. ORR per RECIST 1.1 [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1/Dose escalation

  2. Incidence and severity of TEAEs [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion

  3. Incidence and severity of AESIs [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion

  4. Incidence and severity of SAEs [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion

  5. Incidence and severity of grade ≥3 laboratory abnormalities [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion

  6. REGN5093 Pharmacokinetics (PK) [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion

  7. REGN5093 concentrations in serum over time [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion

  8. Duration of response (DOR) per RECIST 1.1. [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1 and 2

  9. Disease control rate (DCR) per RECIST 1.1. [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1 and 2

  10. Progression free survival (PFS) per RECIST 1.1. [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1 and 2

  11. Overall survival (OS) [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1 and 2

  12. Immunogenicity as measured by Anti-drug antibodies (ADA) to REGN5093 [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1 and 2



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Histologically confirmed NSCLC that is at advanced stage. Advanced is defined as unresectable or metastatic disease. Patients must have exhausted all approved available therapies appropriate for the patient.
  • Has available archival tumor tissue, unless discussed with the medical monitor.
  • Willing to provide tumor tissue from newly obtained biopsy. Newly obtained biopsies at screening are required unless medically contra-indicated and discussed with the medical monitor. For patients in expansion cohorts, biopsies should be taken from tumor site which has not been irradiated previously and is not the only measurable target lesion.
  • Previously documented presence of MET alterations: either MET-exon14 gene mutation and/or MET gene amplification, and/or elevated MET protein expression, as defined 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 or 5 half-lives of the prior treatment whichever is shorter with a minimum of 7 days from the first dose of study therapy
  • Has not yet recovered (i.e. grade ≤1 or baseline) from any acute toxicities resulting from prior therapy except as described in the protocol
  • Has received radiation therapy or major surgery within 14 days of first administration of study drug or has not recovered (i.e. grade ≤1 or baseline) from AEs, except for laboratory changes as described in the protocol and patients with grade ≤2 neuropathy
  • For expansion cohorts only: prior treatment with MET-targeted biologic therapy (function-blocking antibodies or ADCs)
  • For expansion cohorts only (except cohort 1A) prior treatment with any MET-targeted agent including small molecule tyrosine kinase inhibitors eg, crizotinib, capmatinib, tepotinib, as defined in the protocol
  • Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease or spinal cord compression as defined in the protocol

Note: Other protocol defined Inclusion/Exclusion criteria apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04077099


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, Alabama
Regeneron Research Facility Recruiting
Birmingham, Alabama, United States, 35294
United States, California
Regeneron Research Facility Recruiting
Orange, California, United States, 92868
United States, District of Columbia
Regeneron Research Facility Recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Regeneron Research Facility Recruiting
Tampa, Florida, United States, 33612
United States, Kentucky
Regeneron Research Facility Recruiting
Lexington, Kentucky, United States, 40536
United States, Massachusetts
Regeneron Research Facility Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Regeneron Research Facility Recruiting
Detroit, Michigan, United States, 48202
United States, Missouri
Regeneron Research Facility Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Regeneron Research Facility Recruiting
New York, New York, United States, 10016
Regeneron Research Facility Recruiting
New York, New York, United States, 10029
Regeneron Research Facility Recruiting
New York, New York, United States, 10065
United States, North Carolina
Regeneron Research Facility Completed
Durham, North Carolina, United States, 27710
United States, Oklahoma
Regeneron Research Facility Completed
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Regeneron Research Facility Recruiting
Philadelphia, Pennsylvania, United States, 19111
Regeneron Research Facility Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Regeneron Research Facility Recruiting
Dallas, Texas, United States, 75390
Regeneron Research Facility Recruiting
Houston, Texas, United States, 77030
France
Regeneron Research Facility Recruiting
Bordeaux Cedex 9, France, 33076
Regeneron Research Facility Recruiting
Dijon Cedex, France, 21034
Regeneron Research Facility Recruiting
Grenoble, France, 38043
Regeneron Research Facility Recruiting
Montpellier, France, 34295
Regeneron Research Facility Recruiting
Rennes Cedex 9, France, 35033
Korea, Republic of
Regeneron Research Facility Recruiting
Gyeonggi do, Gyeonggi, Korea, Republic of, 10408
Regeneron Research Facility Recruiting
Suwon, Gyeonggi, Korea, Republic of, 16247
Regeneron Research Facility Recruiting
Seoul, Korea, Republic of, 03080
Regeneron Research Facility Recruiting
Seoul, Korea, Republic of, 03722
Regeneron Research Facility Recruiting
Seoul, Korea, Republic of, 05505
Regeneron Research Facility Recruiting
Seoul, Korea, Republic of, 06351
Regeneron Research Facility Recruiting
Seoul, Korea, Republic of, 06591
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04077099    
Other Study ID Numbers: R5093-ONC-1863
2019-001908-38 ( EudraCT Number )
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: June 16, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, EMA, PMDA, etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
MET (mesenchymal-epithelial transition factor)
HGF (Hepatocyte Growth Factor)
NSCLC (non-small cell lung cancer)
MET-altered advanced
Unresectable
Metastatic disease
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms