REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04077099
• Other study ID #: R5093-ONC-1863
• Secondary ID: 2019-001908-38
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: January 7, 2020
• Est. completion date: October 20, 2024

Study information

• Verified date: March 2024
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: October 20, 2024
• Est. primary completion date: October 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• NSCLC

Intervention

Drug:
• REGN5093
Intravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase.

Locations

Country	Name	City	State
France	Regeneron Research Facility	Bordeaux Cedex 9
France	Regeneron Study Site	Caen cedex
France	Regeneron Research Facility	Dijon Cedex
France	Regeneron Research Facility	Grenoble
France	Regeneron Research Facility	Montpellier
France	Regeneron Research Facility	Rennes Cedex 9
Korea, Republic of	Regeneron Research Facility	Gyeonggi do	Gyeonggi
Korea, Republic of	Regeneron Research Facility	Seoul
Korea, Republic of	Regeneron Research Facility	Seoul
Korea, Republic of	Regeneron Research Facility	Seoul
Korea, Republic of	Regeneron Research Facility	Seoul
Korea, Republic of	Regeneron Research Facility	Seoul
Korea, Republic of	Regeneron Research Facility	Suwon	Gyeonggi
United States	Regeneron Research Facility	Birmingham	Alabama
United States	Regeneron Research Facility	Boston	Massachusetts
United States	Regeneron Research Facility	Dallas	Texas
United States	Regeneron Research Facility	Detroit	Michigan
United States	Regeneron Research Facility	Durham	North Carolina
United States	Regeneron Research Facility	Houston	Texas
United States	Regeneron Research Facility	Lexington	Kentucky
United States	Regeneron Research Facility	New York	New York
United States	Regeneron Research Facility	New York	New York
United States	Regeneron Research Facility	New York	New York
United States	Regeneron Research Facility	Oklahoma City	Oklahoma
United States	Regeneron Research Facility	Orange	California
United States	Regeneron Research Facility	Philadelphia	Pennsylvania
United States	Regeneron Research Facility	Pittsburgh	Pennsylvania
United States	Regeneron Research Facility	Saint Louis	Missouri
United States	Regeneron Research Facility	Tampa	Florida
United States	Regeneron Research Facility	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Dose Limiting Toxicities	Phase 1/Dose escalation	Up to 21 days
Primary	Incidence and severity of treatment-emergent adverse events	Phase 1/Dose escalation	Through study completion, an average of 4 years
Primary	Incidence and severity of adverse events of special interest (AESIs)	Phase 1/Dose escalation	Through study completion, an average of 4 years
Primary	Incidence and severity of serious adverse events (SAEs)	Phase 1/Dose escalation	Through study completion, an average of 4 years
Primary	Incidence and severity of grade =3 laboratory abnormalities	Phase 1/Dose escalation	Through study completion, an average of 4 years
Primary	REGN5093 concentrations in serum over time	Phase 1/Dose escalation	Through study completion, an average of 4 years
Primary	Objective response rate (ORR) per RECIST 1.1	Phase 2/Dose expansion	Through study completion, an average of 4 years
Secondary	ORR per RECIST 1.1	Phase 1/Dose escalation	Through study completion, an average of 4 years
Secondary	Incidence and severity of TEAEs	Phase 2/Dose expansion	Through study completion, an average of 4 years
Secondary	Incidence and severity of AESIs	Phase 2/Dose expansion	Through study completion, an average of 4 years
Secondary	Incidence and severity of SAEs	Phase 2/Dose expansion	Through study completion, an average of 4 years
Secondary	Incidence and severity of grade =3 laboratory abnormalities	Phase 2/Dose expansion	Through study completion, an average of 4 years
Secondary	REGN5093 Pharmacokinetics (PK)	Phase 2/Dose expansion	Through study completion, an average of 4 years
Secondary	REGN5093 concentrations in serum over time	Phase 2/Dose expansion	Through study completion, an average of 4 years
Secondary	Duration of response (DOR) per RECIST 1.1.	Phase 1 and 2	Through study completion, an average of 4 years
Secondary	Disease control rate (DCR) per RECIST 1.1.	Phase 1 and 2	Through study completion, an average of 4 years
Secondary	Progression free survival (PFS) per RECIST 1.1.	Phase 1 and 2	Through study completion, an average of 4 years
Secondary	Overall survival (OS)	Phase 1 and 2	Through study completion, an average of 4 years
Secondary	Immunogenicity as measured by Anti-drug antibodies (ADA) to REGN5093	Phase 1 and 2	Through study completion, an average of 4 years