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

Primary Purpose

NSCLC

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
REGN5093
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSCLC focused on measuring MET (mesenchymal-epithelial transition factor), HGF (Hepatocyte Growth Factor), NSCLC (non-small cell lung cancer), MET-altered advanced, Unresectable, Metastatic disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Study Site
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

REGN5093

Arm Description

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

Outcomes

Primary Outcome Measures

Number of patients with Dose Limiting Toxicities
Phase 1/Dose escalation
Incidence and severity of treatment-emergent adverse events
Phase 1/Dose escalation
Incidence and severity of adverse events of special interest (AESIs)
Phase 1/Dose escalation
Incidence and severity of serious adverse events (SAEs)
Phase 1/Dose escalation
Incidence and severity of grade ≥3 laboratory abnormalities
Phase 1/Dose escalation
REGN5093 concentrations in serum over time
Phase 1/Dose escalation
Objective response rate (ORR) per RECIST 1.1
Phase 2/Dose expansion

Secondary Outcome Measures

ORR per RECIST 1.1
Phase 1/Dose escalation
Incidence and severity of TEAEs
Phase 2/Dose expansion
Incidence and severity of AESIs
Phase 2/Dose expansion
Incidence and severity of SAEs
Phase 2/Dose expansion
Incidence and severity of grade ≥3 laboratory abnormalities
Phase 2/Dose expansion
REGN5093 Pharmacokinetics (PK)
Phase 2/Dose expansion
REGN5093 concentrations in serum over time
Phase 2/Dose expansion
Duration of response (DOR) per RECIST 1.1.
Phase 1 and 2
Disease control rate (DCR) per RECIST 1.1.
Phase 1 and 2
Progression free survival (PFS) per RECIST 1.1.
Phase 1 and 2
Overall survival (OS)
Phase 1 and 2
Immunogenicity as measured by Anti-drug antibodies (ADA) to REGN5093
Phase 1 and 2

Full Information

First Posted
August 13, 2019
Last Updated
March 8, 2023
Sponsor
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04077099
Brief Title
REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer
Official Title
A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
October 20, 2024 (Anticipated)
Study Completion Date
October 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC
Keywords
MET (mesenchymal-epithelial transition factor), HGF (Hepatocyte Growth Factor), NSCLC (non-small cell lung cancer), MET-altered advanced, Unresectable, Metastatic disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REGN5093
Arm Type
Experimental
Arm Description
Monotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2)
Intervention Type
Drug
Intervention Name(s)
REGN5093
Intervention Description
Intravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase.
Primary Outcome Measure Information:
Title
Number of patients with Dose Limiting Toxicities
Description
Phase 1/Dose escalation
Time Frame
Up to 21 days
Title
Incidence and severity of treatment-emergent adverse events
Description
Phase 1/Dose escalation
Time Frame
Through study completion, an average of 4 years
Title
Incidence and severity of adverse events of special interest (AESIs)
Description
Phase 1/Dose escalation
Time Frame
Through study completion, an average of 4 years
Title
Incidence and severity of serious adverse events (SAEs)
Description
Phase 1/Dose escalation
Time Frame
Through study completion, an average of 4 years
Title
Incidence and severity of grade ≥3 laboratory abnormalities
Description
Phase 1/Dose escalation
Time Frame
Through study completion, an average of 4 years
Title
REGN5093 concentrations in serum over time
Description
Phase 1/Dose escalation
Time Frame
Through study completion, an average of 4 years
Title
Objective response rate (ORR) per RECIST 1.1
Description
Phase 2/Dose expansion
Time Frame
Through study completion, an average of 4 years
Secondary Outcome Measure Information:
Title
ORR per RECIST 1.1
Description
Phase 1/Dose escalation
Time Frame
Through study completion, an average of 4 years
Title
Incidence and severity of TEAEs
Description
Phase 2/Dose expansion
Time Frame
Through study completion, an average of 4 years
Title
Incidence and severity of AESIs
Description
Phase 2/Dose expansion
Time Frame
Through study completion, an average of 4 years
Title
Incidence and severity of SAEs
Description
Phase 2/Dose expansion
Time Frame
Through study completion, an average of 4 years
Title
Incidence and severity of grade ≥3 laboratory abnormalities
Description
Phase 2/Dose expansion
Time Frame
Through study completion, an average of 4 years
Title
REGN5093 Pharmacokinetics (PK)
Description
Phase 2/Dose expansion
Time Frame
Through study completion, an average of 4 years
Title
REGN5093 concentrations in serum over time
Description
Phase 2/Dose expansion
Time Frame
Through study completion, an average of 4 years
Title
Duration of response (DOR) per RECIST 1.1.
Description
Phase 1 and 2
Time Frame
Through study completion, an average of 4 years
Title
Disease control rate (DCR) per RECIST 1.1.
Description
Phase 1 and 2
Time Frame
Through study completion, an average of 4 years
Title
Progression free survival (PFS) per RECIST 1.1.
Description
Phase 1 and 2
Time Frame
Through study completion, an average of 4 years
Title
Overall survival (OS)
Description
Phase 1 and 2
Time Frame
Through study completion, an average of 4 years
Title
Immunogenicity as measured by Anti-drug antibodies (ADA) to REGN5093
Description
Phase 1 and 2
Time Frame
Through study completion, an average of 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Regeneron Research Facility
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Regeneron Research Facility
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Regeneron Research Facility
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Regeneron Research Facility
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Regeneron Research Facility
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Regeneron Research Facility
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Regeneron Research Facility
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Regeneron Research Facility
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Regeneron Research Facility
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Regeneron Research Facility
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Regeneron Research Facility
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Regeneron Research Facility
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Regeneron Research Facility
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Regeneron Research Facility
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Regeneron Research Facility
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Regeneron Research Facility
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Regeneron Research Facility
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Regeneron Research Facility
City
Bordeaux Cedex 9
ZIP/Postal Code
33076
Country
France
Facility Name
Regeneron Study Site
City
Caen cedex
ZIP/Postal Code
14076
Country
France
Facility Name
Regeneron Research Facility
City
Dijon Cedex
ZIP/Postal Code
21034
Country
France
Facility Name
Regeneron Research Facility
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Regeneron Research Facility
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Regeneron Research Facility
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Regeneron Research Facility
City
Gyeonggi do
State/Province
Gyeonggi
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Regeneron Research Facility
City
Suwon
State/Province
Gyeonggi
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Regeneron Research Facility
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Regeneron Research Facility
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Regeneron Research Facility
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Regeneron Research Facility
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Regeneron Research Facility
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD Sharing 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.
IPD Sharing 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).
IPD Sharing URL
https://vivli.org/

Learn more about this trial

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

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