NSCLC
Conditions
Keywords
MET (mesenchymal-epithelial transition factor), HGF (Hepatocyte Growth Factor), NSCLC (non-small cell lung cancer), MET-altered advanced, Unresectable, Metastatic disease
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
Interventions
DRUGREGN5093
Intravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase.
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Dose Limiting Toxicities (DLTs) | Up to 21 days | Phase 1/Dose escalation |
| Incidence and severity of treatment-emergent adverse events (TEAEs) | Through study completion, an average of 12 years | Phase 1/Dose escalation |
| Incidence and severity of adverse events of special interest (AESIs) | Through study completion, an average of 12 years | Phase 1/Dose escalation |
| Incidence and severity of serious adverse events (SAEs) | Through study completion, an average of 12 years | Phase 1/Dose escalation |
| Incidence and severity of grade ≥3 laboratory abnormalities | Through study completion, an average of 12 years | Phase 1/Dose escalation |
| REGN5093 concentrations in serum over time | Through study completion, an average of 12 years | Phase 1/Dose escalation |
| Objective response rate (ORR) per RECIST 1.1 | Through study completion, an average of 12 years | Phase 2/Dose expansion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR per RECIST 1.1 | Through study completion, an average of 12 years | Phase 1/Dose escalation |
| Incidence and severity of TEAEs | Through study completion, an average of 12 years | Phase 2/Dose expansion |
| Incidence and severity of AESIs | Through study completion, an average of 12 years | Phase 2/Dose expansion |
| Incidence and severity of SAEs | Through study completion, an average of 12 years | Phase 2/Dose expansion |
| Incidence and severity of grade ≥3 laboratory abnormalities | Through study completion, an average of 12 years | Phase 2/Dose expansion |
| REGN5093 Pharmacokinetics (PK) | Through study completion, an average of 12 years | Phase 2/Dose expansion |
| REGN5093 concentrations in serum over time | Through study completion, an average of 12 years | Phase 2/Dose expansion |
| Duration of response (DOR) per RECIST 1.1. | Through study completion, an average of 12 years | Phase 1 and 2 |
| Disease control rate (DCR) per RECIST 1.1. | Through study completion, an average of 12 years | Phase 1 and 2 |
| Progression free survival (PFS) per RECIST 1.1. | Through study completion, an average of 12 years | Phase 1 and 2 |
| Overall survival (OS) | Through study completion, an average of 12 years | Phase 1 and 2 |
| Time to response (TTR) per RECIST 1.1 | Through study completion, an average of 12 years | Phase 1 and 2 |
| Incidence of anti-drug antibodies (ADA) to REGN5093 | Through study completion, an average of 12 years | Phase 1 and 2 |
| Titer of ADA to REGN5093 | Through study completion, an average of 12 years | Phase 1 and 2 |
Countries
France, South Korea, United States
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed