Clinical trial NCT04077099: A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: NSCLC
Keywords: MET (mesenchymal-epithelial transition factor)
HGF (Hepatocyte Growth Factor)
NSCLC (non-small cell lung cancer)
MET-altered advanced
Unresectable
Metastatic disease
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-09-04
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: Number of patients with Dose Limiting Toxicities (DLTs)
timeFrame: Up to 21 days
measure: Incidence and severity of treatment-emergent adverse events (TEAEs)
timeFrame: Through study completion, an average of 12 years
measure: Incidence and severity of adverse events of special interest (AESIs)
timeFrame: Through study completion, an average of 12 years
measure: Incidence and severity of serious adverse events (SAEs)
timeFrame: Through study completion, an average of 12 years
measure: Incidence and severity of grade ≥3 laboratory abnormalities
timeFrame: Through study completion, an average of 12 years
measure: REGN5093 concentrations in serum over time
timeFrame: Through study completion, an average of 12 years
measure: Objective response rate (ORR) per RECIST 1.1
timeFrame: Through study completion, an average of 12 years
Secondary outcomes:
measure: ORR per RECIST 1.1
timeFrame: Through study completion, an average of 12 years
measure: Incidence and severity of TEAEs
timeFrame: Through study completion, an average of 12 years
measure: Incidence and severity of AESIs
timeFrame: Through study completion, an average of 12 years
measure: Incidence and severity of SAEs
timeFrame: Through study completion, an average of 12 years
measure: Incidence and severity of grade ≥3 laboratory abnormalities
timeFrame: Through study completion, an average of 12 years
measure: REGN5093 Pharmacokinetics (PK)
timeFrame: Through study completion, an average of 12 years
measure: REGN5093 concentrations in serum over time
timeFrame: Through study completion, an average of 12 years
measure: Duration of response (DOR) per RECIST 1.1.
timeFrame: Through study completion, an average of 12 years
measure: Disease control rate (DCR) per RECIST 1.1.
timeFrame: Through study completion, an average of 12 years
measure: Progression free survival (PFS) per RECIST 1.1.
timeFrame: Through study completion, an average of 12 years
measure: Overall survival (OS)
timeFrame: Through study completion, an average of 12 years
measure: Time to response (TTR) per RECIST 1.1
timeFrame: Through study completion, an average of 12 years
measure: Incidence of anti-drug antibodies (ADA) to REGN5093
timeFrame: Through study completion, an average of 12 years
measure: Titer of ADA to REGN5093
timeFrame: Through study completion, an average of 12 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Regeneron Research Facility
state: Alabama
city: Orange
country: United States
facility: Regeneron Research Facility
state: California
city: Washington
country: United States
facility: Regeneron Research Facility
state: District of Columbia
city: Tampa
country: United States
facility: Regeneron Research Facility
state: Florida
city: Lexington
country: United States
facility: Regeneron Research Facility
state: Kentucky
city: Boston
country: United States
facility: Regeneron Research Facility
state: Massachusetts
city: Detroit
country: United States
facility: Regeneron Research Facility
state: Michigan
city: Saint Louis
country: United States
facility: Regeneron Research Facility
state: Missouri
city: New York
country: United States
facility: Regeneron Research Facility
state: New York
city: New York
country: United States
facility: Regeneron Research Facility
state: New York
city: New York
country: United States
facility: Regeneron Research Facility
state: New York
city: Durham
country: United States
facility: Regeneron Research Facility
state: North Carolina
city: Oklahoma City
country: United States
facility: Regeneron Research Facility
state: Oklahoma
city: Philadelphia
country: United States
facility: Regeneron Research Facility
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Regeneron Research Facility
state: Pennsylvania
city: Dallas
country: United States
facility: Regeneron Research Facility
state: Texas
city: Houston
country: United States
facility: Regeneron Research Facility
state: Texas
city: Bordeaux Cedex 9
country: France
facility: Regeneron Research Facility
city: Caen cedex
country: France
facility: Regeneron Study Site
city: Dijon Cedex
country: France
facility: Regeneron Research Facility
city: Grenoble
country: France
facility: Regeneron Research Facility
city: Montpellier
country: France
facility: Regeneron Research Facility
city: Rennes Cedex 9
country: France
facility: Regeneron Research Facility
city: Gyeonggi do
country: Korea, Republic of
facility: Regeneron Research Facility
state: Gyeonggi
city: Suwon
country: Korea, Republic of
facility: Regeneron Research Facility
state: Gyeonggi
city: Seoul
country: Korea, Republic of
facility: Regeneron Research Facility
city: Seoul
country: Korea, Republic of
facility: Regeneron Research Facility
city: Seoul
country: Korea, Republic of
facility: Regeneron Research Facility
city: Seoul
country: Korea, Republic of
facility: Regeneron Research Facility
city: Seoul
country: Korea, Republic of
facility: Regeneron Research Facility
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: