A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer

Regeneron Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: NSCLC

Treatments: Drug: REGN5093

Study type: Interventional

Funder types: Industry

Identifiers

NCT04077099

2023-506248-18-00 (Registry Identifier)

2019-001908-38 (EudraCT Number)

R5093-ONC-1863

Details and patient eligibility

About

This study will evaluate REGN5093 for the treatment of Non-Small Cell Lung Cancer (NSCLC) with MET alteration. The main purpose of this study is to determine the safety, tolerability, and effectiveness of REGN5093.

The study has two phases. The main goal of Phase 1 is to determine a safe dose(s) of REGN5093. The main goal of phase 2 of the study is to use the REGN5093 drug dose(s) found in Phase 1 to see how well REGN5093 works to shrink tumors.

The study is looking at several other research questions, including:

• Side effects that may be experienced by people taking REGN5093
• How REGN5093 works in the body
• How much REGN5093 is present in the blood
• To see if REGN5093 works to reduce or delay the progression of cancer
• How long it takes REGN5093 to work in the body

Enrollment: 231 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Histologically confirmed advanced NSCLC that is unresectable or metastatic as described in the protocol
2. Willing to provide tumor tissue as described in the protocol
3. Documented presence of MET alteration as described in the protocol.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Adequate organ and bone marrow function as described in the protocol

Key Exclusion Criteria:

1. Has received treatment with an approved systemic therapy or has participated in any study of an investigational agent or investigational device within 2 weeks as described in the protocol
2. Has not yet recovered from any acute toxicities resulting from prior therapy with certain exceptions as described in the protocol
3. Has received radiation therapy or major surgery within 14 days as described in the protocol
4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease or spinal cord compression as defined in the protocol
5. Uncontrolled infection as described in the protocol

Note: Other protocol defined Inclusion/Exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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231 participants in 1 patient group

REGN5093

Experimental group

Description:

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

Treatment:

Drug: REGN5093