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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-07

Study Completion Date

2032-04-22

Brief Summary

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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

Detailed Description

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Conditions

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NSCLC

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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REGN5093

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

Group Type EXPERIMENTAL

REGN5093

Intervention Type DRUG

Intravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase.

Interventions

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REGN5093

Intravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase.

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Seoul, , South Korea

Site Status RECRUITING

Countries

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United States France South Korea

Central Contacts

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Clinical Trials Administrator

Role: CONTACT

Phone: 844-734-6643

Email: [email protected]

Other Identifiers

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2019-001908-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-506248-18-00

Identifier Type: CTIS

Identifier Source: secondary_id

R5093-ONC-1863

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

REGN5093

REGN5093

Interventions

REGN5093

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Regeneron Pharmaceuticals

Responsible Party

Principal Investigators

Clinical Trial Management

Locations

University of Alabama at Birmingham

University of California Irvine Medical Center - Bldg 56, RT81, Rm 241

Georgetown University Medical Center

Moffitt Cancer Center - McKinley Drive

University of Kentucky, Markey Cancer Center Clinical Research Organization

DNU_Massachusetts General Hospital_DNU

Dana Farber Harvard Cancer Center Consortium

Henry Ford Health System

Washington University School of Medicine

NYU Cancer Institute

Icahn School of Medicine at Mount Sinai

Memorial Sloan Kettering Cancer Center

Duke Cancer Center

Stephenson Cancer Center

Fox Chase Cancer Center

University of Pittsburgh UPMC - Clinical Research Services

Harold C. Simmons Comprehensive Cancer Center

The University of Texas MD Anderson Cancer Center

Centre Georges Francois Leclerc

Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

Centre Francois Baclesse (CFB)

Institut Bergonie

Centre Hospitalier Universitaire de Grenoble

Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve

National Cancer Center

The Catholic University Of Korea St. Vincent's Hospital

Haeundae Paik Hospital

Pusan National University Hospital

Asan Medical Center

Samsung Medical Center

Seol St. Mary's Hospital

Seoul National University Hospital

Severance Hospital

Countries

Central Contacts

Clinical Trials Administrator

Other Identifiers

2019-001908-38

2023-506248-18-00

R5093-ONC-1863