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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 : October 29, 2021
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 13, 2019
First Posted Date  ICMJE September 4, 2019
Last Update Posted Date October 29, 2021
Actual Study Start Date  ICMJE January 7, 2020
Estimated Primary Completion Date October 20, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2021)
  • Number of patients with Dose Limiting Toxicities [ Time Frame: Up to 21 days ]
    Phase 1/Dose escalation
  • Incidence and severity of treatment-emergent adverse events [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1/Dose escalation
  • Incidence and severity of adverse events of special interest (AESIs) [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1/Dose escalation
  • Incidence and severity of serious adverse events (SAEs) [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1/Dose escalation
  • Incidence and severity of grade ≥3 laboratory abnormalities [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1/Dose escalation
  • REGN5093 concentrations in serum over time [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1/Dose escalation
  • Objective response rate (ORR) per RECIST 1.1 [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2019)
  • Number of patients with Dose Limiting Toxicities [ Time Frame: Up to 21 days ]
    Phase 1/Dose escalation
  • Incidence and severity of treatment-emergent adverse events [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1/Dose escalation
  • Incidence and severity of adverse events of special interest (AESIs) [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1/Dose escalation
  • Incidence and severity of serious adverse events (SAEs) [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1/Dose escalation
  • Incidence and severity of ≥grade 3 laboratory abnormalities [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1/Dose escalation
  • REGN5093 concentrations in serum over time [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1/Dose escalation
  • Objective response rate (ORR) per RECIST 1.1 [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2021)
  • ORR per RECIST 1.1 [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1/Dose escalation
  • Incidence and severity of TEAEs [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion
  • Incidence and severity of AESIs [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion
  • Incidence and severity of SAEs [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion
  • Incidence and severity of grade ≥3 laboratory abnormalities [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion
  • REGN5093 Pharmacokinetics (PK) [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion
  • REGN5093 concentrations in serum over time [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion
  • Duration of response (DOR) per RECIST 1.1. [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1 and 2
  • Disease control rate (DCR) per RECIST 1.1. [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1 and 2
  • Progression free survival (PFS) per RECIST 1.1. [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1 and 2
  • Overall survival (OS) [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1 and 2
  • Immunogenicity as measured by Anti-drug antibodies (ADA) to REGN5093 [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1 and 2
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2019)
  • ORR per RECIST 1.1 [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1/Dose escalation
  • Incidence and severity of TEAEs [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion
  • Incidence and severity of AESIs [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion
  • Incidence and severity of SAEs [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion
  • Incidence and severity of ≥grade 3 laboratory abnormalities [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion
  • REGN5093 Pharmacokinetics (PK) [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion
  • REGN5093 concentrations in serum over time [ Time Frame: Through study completion, an average of 4 years ]
    Phase 2/Dose expansion
  • Duration of response (DOR) per RECIST 1.1. [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1 and 2
  • Disease control rate (DCR) per RECIST 1.1. [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1 and 2
  • Progression free survival (PFS) per RECIST 1.1. [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1 and 2
  • Overall survival (OS) [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1 and 2
  • Immunogenicity as measured by Anti-drug antibodies (ADA) to REGN5093 [ Time Frame: Through study completion, an average of 4 years ]
    Phase 1 and 2
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer
Official Title  ICMJE A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer
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)

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE NSCLC
Intervention  ICMJE Drug: REGN5093
Intravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase.
Study Arms  ICMJE Experimental: REGN5093
Monotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2)
Intervention: Drug: REGN5093
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 7, 2021)
111
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2019)
102
Estimated Study Completion Date  ICMJE October 20, 2024
Estimated Primary Completion Date October 20, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com
Listed Location Countries  ICMJE France,   Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04077099
Other Study ID Numbers  ICMJE R5093-ONC-1863
2019-001908-38 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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/
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP