Clinical Trials /

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

NCT04077099

Description:

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)

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: R5093-ONC-1863
  • SECONDARY ID: 2019-001908-38
  • NCT ID: NCT04077099

Conditions

  • NSCLC

Interventions

DrugSynonymsArms
REGN5093REGN5093

Purpose

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)

Trial Arms

NameTypeDescriptionInterventions
REGN5093ExperimentalMonotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2)
  • REGN5093

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.

          -  Has available archival tumor tissue

          -  Willing to provide tumor tissue from newly obtained biopsy from tumor site which has
             not been irradiated previously and is not the only measurable lesion. Newly obtained
             biopsies at screening are required unless discussed with the medical monitor.
             Provision of archival tumor tissue is mandated.

          -  Previously documented presence of MET alterations: either MET-exon14 gene mutation
             and/or MET gene amplification, and/or elevated MET protein expression

        Key Exclusion Criteria:

          -  Has received treatment with an approved systemic therapy within 3 weeks or has not yet
             recovered (i.e. ≤Grade 1 or baseline) from any acute toxicities except for laboratory
             changes as described in the protocol and patients with ≤Grade 2 neuropathy

          -  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

          -  Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease or
             spinal cord compression as defined in the protocol

          -  Known allergy to doxycycline or other tetracycline antibiotics

        Note: Other protocol defined Inclusion/Exclusion criteria apply.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patients with Dose Limiting Toxicities
Time Frame:Up to 21 days
Safety Issue:
Description:Phase 1/Dose escalation

Secondary Outcome Measures

Measure:ORR per RECIST 1.1
Time Frame:Through study completion, an average of 4 years
Safety Issue:
Description:Phase 1/Dose escalation
Measure:Incidence and severity of TEAEs
Time Frame:Through study completion, an average of 4 years
Safety Issue:
Description:Phase 2/Dose expansion
Measure:Incidence and severity of AESIs
Time Frame:Through study completion, an average of 4 years
Safety Issue:
Description:Phase 2/Dose expansion
Measure:Incidence and severity of SAEs
Time Frame:Through study completion, an average of 4 years
Safety Issue:
Description:Phase 2/Dose expansion
Measure:Incidence and severity of ≥grade 3 laboratory abnormalities
Time Frame:Through study completion, an average of 4 years
Safety Issue:
Description:Phase 2/Dose expansion
Measure:REGN5093 Pharmacokinetics (PK)
Time Frame:Through study completion, an average of 4 years
Safety Issue:
Description:Phase 2/Dose expansion
Measure:REGN5093 concentrations in serum over time
Time Frame:Through study completion, an average of 4 years
Safety Issue:
Description:Phase 2/Dose expansion
Measure:Duration of response (DOR) per RECIST 1.1.
Time Frame:Through study completion, an average of 4 years
Safety Issue:
Description:Phase 1 and 2
Measure:Disease control rate (DCR) per RECIST 1.1.
Time Frame:Through study completion, an average of 4 years
Safety Issue:
Description:Phase 1 and 2
Measure:Progression free survival (PFS) per RECIST 1.1.
Time Frame:Through study completion, an average of 4 years
Safety Issue:
Description:Phase 1 and 2
Measure:Overall survival (OS)
Time Frame:Through study completion, an average of 4 years
Safety Issue:
Description:Phase 1 and 2
Measure:Immunogenicity as measured by Anti-drug antibodies (ADA) to REGN5093
Time Frame:Through study completion, an average of 4 years
Safety Issue:
Description:Phase 1 and 2

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Regeneron Pharmaceuticals

Trial Keywords

  • MET (mesenchymal-epithelial transition factor)
  • HGF (Hepatocyte Growth Factor)
  • NSCLC (non-small cell lung cancer)
  • MET-altered advanced
  • Unresectable
  • Metastatic disease

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