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

Protocol # :
Disease Sites
Principal Investigator
Awad, Mark
Site Investigator
Heist, Rebecca, Suk
Site Research Nurses
Janell, Samantha
Kuberski, Heather, D.
Souza, Joseph
Stober, Lisa, L.
Sullivan, Molly, O'Brien
Wanat, Alexandra

Trial 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)

Eligibility Requirements

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.