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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001908-38 | EudraCT Number | ||
| 2023-506248-18-00 | EU Trial (CTIS) Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN5093 | Experimental | Monotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN5093 | Drug | Intravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with Dose Limiting Toxicities (DLTs) | Phase 1/Dose escalation | Up to 21 days |
| Incidence and severity of treatment-emergent adverse events (TEAEs) | Phase 1/Dose escalation | Through study completion, an average of 12 years |
| Incidence and severity of adverse events of special interest (AESIs) | Phase 1/Dose escalation | Through study completion, an average of 12 years |
| Incidence and severity of serious adverse events (SAEs) | Phase 1/Dose escalation | Through study completion, an average of 12 years |
| Incidence and severity of grade ≥3 laboratory abnormalities | Phase 1/Dose escalation | Through study completion, an average of 12 years |
| REGN5093 concentrations in serum over time | Phase 1/Dose escalation | Through study completion, an average of 12 years |
| Objective response rate (ORR) per RECIST 1.1 | Phase 2/Dose expansion | Through study completion, an average of 12 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR per RECIST 1.1 | Phase 1/Dose escalation | Through study completion, an average of 12 years |
| Incidence and severity of TEAEs | Phase 2/Dose expansion |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Withdrawn | Birmingham | Alabama | 35294 | United States | |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| Through study completion, an average of 12 years |
| Incidence and severity of AESIs | Phase 2/Dose expansion | Through study completion, an average of 12 years |
| Incidence and severity of SAEs | Phase 2/Dose expansion | Through study completion, an average of 12 years |
| Incidence and severity of grade ≥3 laboratory abnormalities | Phase 2/Dose expansion | Through study completion, an average of 12 years |
| REGN5093 Pharmacokinetics (PK) | Phase 2/Dose expansion | Through study completion, an average of 12 years |
| REGN5093 concentrations in serum over time | Phase 2/Dose expansion | Through study completion, an average of 12 years |
| Duration of response (DOR) per RECIST 1.1. | Phase 1 and 2 | Through study completion, an average of 12 years |
| Disease control rate (DCR) per RECIST 1.1. | Phase 1 and 2 | Through study completion, an average of 12 years |
| Progression free survival (PFS) per RECIST 1.1. | Phase 1 and 2 | Through study completion, an average of 12 years |
| Overall survival (OS) | Phase 1 and 2 | Through study completion, an average of 12 years |
| Time to response (TTR) per RECIST 1.1 | Phase 1 and 2 | Through study completion, an average of 12 years |
| Incidence of anti-drug antibodies (ADA) to REGN5093 | Phase 1 and 2 | Through study completion, an average of 12 years |
| Titer of ADA to REGN5093 | Phase 1 and 2 | Through study completion, an average of 12 years |
| University of California Irvine Medical Center - Bldg 56, RT81, Rm 241 |
| Completed |
| Orange |
| California |
| 92868 |
| United States |
| Georgetown University Medical Center | Completed | Washington D.C. | District of Columbia | 20007 | United States |
| Moffitt Cancer Center - McKinley Drive | Recruiting | Tampa | Florida | 33612 | United States |
| University of Kentucky, Markey Cancer Center Clinical Research Organization | Withdrawn | Lexington | Kentucky | 40536 | United States |
| DNU_Massachusetts General Hospital_DNU | Withdrawn | Boston | Massachusetts | 02114 | United States |
| Dana Farber Harvard Cancer Center Consortium | Completed | Boston | Massachusetts | 02215 | United States |
| Henry Ford Health System | Withdrawn | Detroit | Michigan | 48202 | United States |
| Washington University School of Medicine | Withdrawn | St Louis | Missouri | 63110 | United States |
| NYU Cancer Institute | Withdrawn | New York | New York | 10016 | United States |
| Icahn School of Medicine at Mount Sinai | Completed | New York | New York | 10029 | United States |
| Memorial Sloan Kettering Cancer Center | Completed | New York | New York | 10065 | United States |
| Duke Cancer Center | Withdrawn | Durham | North Carolina | 27710 | United States |
| Stephenson Cancer Center | Withdrawn | Oklahoma City | Oklahoma | 73104 | United States |
| Fox Chase Cancer Center | Withdrawn | Philadelphia | Pennsylvania | 19111 | United States |
| University of Pittsburgh UPMC - Clinical Research Services | Completed | Pittsburgh | Pennsylvania | 15232 | United States |
| Harold C. Simmons Comprehensive Cancer Center | Withdrawn | Dallas | Texas | 75235 | United States |
| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Centre Georges Francois Leclerc | Withdrawn | Dijon | Bourgogne-Franche-Comté | 21034 | France |
| Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou | Completed | Rennes | Bretange | 35033 | France |
| Institut Bergonie | Completed | Bordeaux | New Aquitaine | 33076 | France |
| Centre Francois Baclesse (CFB) | Completed | Caen | Normandy | 14076 | France |
| Centre Hospitalier Universitaire de Grenoble | Completed | Grenoble | 38043 | France |
| Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve | Completed | Montpellier | 34295 | France |
| National Cancer Center | Recruiting | Gyeonggi-do | Gyeonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| The Catholic University Of Korea St. Vincent's Hospital | Recruiting | Suwon | Gyeonggi-do | 16247 | South Korea |
| Ajou University Hospital | Recruiting | Suwon | Gyeonggi-do | 16499 | South Korea |
| Haeundae Paik Hospital | Recruiting | Pusan | Gyeongsangnam-do | 48108 | South Korea |
| Chonnam National University Hwasun Hospital | Recruiting | Hwasun | Jeollanam-do | 58128 | South Korea |
| Gachon University Gil Medical Center | Recruiting | Incheon | Namdong-gu | 21565 | South Korea |
| Chungbuk National University Hospital | Recruiting | Cheongju-si | North Chungcheong | 28644 | South Korea |
| Pusan National University Hospital | Recruiting | Busan | 49241 | South Korea |
| Severance Hospital Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Seol St. Mary's Hospital | Completed | Seoul | 06591 | South Korea |
| Boramae Medical Center | Recruiting | Seoul | 07061 | South Korea |
| Korea University Guro Hospital | Recruiting | Seoul | 08308 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 3080 | South Korea |
| ID | Term |
|---|---|
| C564265 | Deafness, Autosomal Recessive 39 |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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