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Clinical Trial 20364

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT04077099

Phase: Phase I/II
Prinicipal Investigator: Jhanelle Gray

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

A Phase 1/2 Study of REGN5093 in Patients with Met-Altered Advanced Non-Small Cell Lung Cancer

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)

Objective

Primary Objective for Phase 1 part of study: 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 NSCLC. Primary Objective of Phase 2 part of study: 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). Secondary Objective for Phase 1 part of the study: To assess preliminary anti-tumor activity of REGN5093 as measured by the ORR per RECIST 1.1. Secondary Objectives for Phase 2 part of study: To assess the safety and tolerability of REGN5093 in each expansion cohort. To assess REGN5093 PK and concentrations in serum. Secondary Objectives of both parts of the study: To assess immunogenicity as measured by anti-drug antibodies (ADA) to REGN5093. To evaluate other measures of preliminary anti-tumor activity. Exploratory Objectives of Phase 2 part of study: To evaluate relationships between efficacy of REGN5093 and baseline MET alteration/mutation or amplification/expression. To assess pharmacodynamic changes in putative serum or plasma biomarkers. To evaluate the impact on efficacy of tumor mutational spectrum at baseline and post-treatment in tissue and in circulating tumor DNA (ctDNA).

Treatments

Therapies

Medications

REGN5093 ()

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

    • 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.

    • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

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