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

• Sponsor: Regeneron Pharmaceuticals (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04077099
• Collaborator: (none)
• Enrollment: 111
• Locations: 30
• Arm: 1
• Anticipated Duration (Months): 57.4
• Patients Per Site: 3.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
NSCLC	Drug: REGN5093	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 111 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer
• Actual Study Start Date: Jan 7, 2020
• Anticipated Primary Completion Date: Oct 20, 2024
• Anticipated Study Completion Date: Oct 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: REGN5093 Monotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2)	Drug: REGN5093; Intravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase.

Outcome Measures

Primary Outcome Measures

1. Number of patients with Dose Limiting Toxicities [Up to 21 days]

   Phase 1/Dose escalation

2. Incidence and severity of treatment-emergent adverse events [Through study completion, an average of 4 years]

   Phase 1/Dose escalation

3. Incidence and severity of adverse events of special interest (AESIs) [Through study completion, an average of 4 years]

   Phase 1/Dose escalation

4. Incidence and severity of serious adverse events (SAEs) [Through study completion, an average of 4 years]

   Phase 1/Dose escalation

5. Incidence and severity of grade ≥3 laboratory abnormalities [Through study completion, an average of 4 years]

   Phase 1/Dose escalation

6. REGN5093 concentrations in serum over time [Through study completion, an average of 4 years]

   Phase 1/Dose escalation

7. Objective response rate (ORR) per RECIST 1.1 [Through study completion, an average of 4 years]

   Phase 2/Dose expansion

Secondary Outcome Measures

1. ORR per RECIST 1.1 [Through study completion, an average of 4 years]

   Phase 1/Dose escalation

2. Incidence and severity of TEAEs [Through study completion, an average of 4 years]

   Phase 2/Dose expansion

3. Incidence and severity of AESIs [Through study completion, an average of 4 years]

   Phase 2/Dose expansion

4. Incidence and severity of SAEs [Through study completion, an average of 4 years]

   Phase 2/Dose expansion

5. Incidence and severity of grade ≥3 laboratory abnormalities [Through study completion, an average of 4 years]

   Phase 2/Dose expansion

6. REGN5093 Pharmacokinetics (PK) [Through study completion, an average of 4 years]

   Phase 2/Dose expansion

7. REGN5093 concentrations in serum over time [Through study completion, an average of 4 years]

   Phase 2/Dose expansion

8. Duration of response (DOR) per RECIST 1.1. [Through study completion, an average of 4 years]

   Phase 1 and 2

9. Disease control rate (DCR) per RECIST 1.1. [Through study completion, an average of 4 years]

   Phase 1 and 2

10. Progression free survival (PFS) per RECIST 1.1. [Through study completion, an average of 4 years]

    Phase 1 and 2

11. Overall survival (OS) [Through study completion, an average of 4 years]

    Phase 1 and 2

12. Immunogenicity as measured by Anti-drug antibodies (ADA) to REGN5093 [Through study completion, an average of 4 years]

    Phase 1 and 2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regeneron Research Facility	Birmingham	Alabama	United States	35294
2	Regeneron Research Facility	Orange	California	United States	92868
3	Regeneron Research Facility	Washington	District of Columbia	United States	20007
4	Regeneron Research Facility	Tampa	Florida	United States	33612
5	Regeneron Research Facility	Lexington	Kentucky	United States	40536
6	Regeneron Research Facility	Boston	Massachusetts	United States	02215
7	Regeneron Research Facility	Detroit	Michigan	United States	48202
8	Regeneron Research Facility	Saint Louis	Missouri	United States	63110
9	Regeneron Research Facility	New York	New York	United States	10016
10	Regeneron Research Facility	New York	New York	United States	10029
11	Regeneron Research Facility	New York	New York	United States	10065
12	Regeneron Research Facility	Durham	North Carolina	United States	27710
13	Regeneron Research Facility	Oklahoma City	Oklahoma	United States	73104
14	Regeneron Research Facility	Philadelphia	Pennsylvania	United States	19111
15	Regeneron Research Facility	Pittsburgh	Pennsylvania	United States	15232
16	Regeneron Research Facility	Dallas	Texas	United States	75390
17	Regeneron Research Facility	Houston	Texas	United States	77030
18	Regeneron Research Facility	Bordeaux Cedex 9		France	33076
19	Regeneron Study Site	Caen cedex		France	14076
20	Regeneron Research Facility	Dijon Cedex		France	21034
21	Regeneron Research Facility	Grenoble		France	38043
22	Regeneron Research Facility	Montpellier		France	34295
23	Regeneron Research Facility	Rennes Cedex 9		France	35033
24	Regeneron Research Facility	Gyeonggi do	Gyeonggi	Korea, Republic of	10408
25	Regeneron Research Facility	Suwon	Gyeonggi	Korea, Republic of	16247
26	Regeneron Research Facility	Seoul		Korea, Republic of	03080
27	Regeneron Research Facility	Seoul		Korea, Republic of	03722
28	Regeneron Research Facility	Seoul		Korea, Republic of	05505
29	Regeneron Research Facility	Seoul		Korea, Republic of	06351
30	Regeneron Research Facility	Seoul		Korea, Republic of	06591

Sponsors and Collaborators

• Regeneron Pharmaceuticals

Investigators

• Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04077099
• Other Study ID Numbers: R5093-ONC-1863; 2019-001908-38
• First Posted: Sep 4, 2019
• Last Update Posted: May 25, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Regeneron Pharmaceuticals: MET (mesenchymal-epithelial transition factor); HGF (Hepatocyte Growth Factor); NSCLC (non-small cell lung cancer); MET-altered advanced; Unresectable; Metastatic disease
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of May 25, 2022