MET-altered non-small cell lung cancer (NSCLC)
Conditions
Brief summary
Phase 1: Number of patients with Dose Limiting Toxicities, Phase 1: Incidence and severity of treatment-emergent adverse events, Phase 1: Incidence and severity of adverse events of special interest (AESIs), Phase 1: Incidence and severity of serious adverse events (SAEs), Phase 1: Incidence and severity of grade ≥3 laboratory abnormalities, Phase 1: REGN5093 concentrations in serum over time, Phase 2: Objective response rate (ORR) per RECIST 1.1
Detailed description
Phase 1: ORR per RECIST 1.1, Phase 2: Incidence and severity of TEAEs, Phase 2: Incidence and severity of AESIs, Phase 2: Incidence and severity of SAEs, Phase 2: Incidence and severity of grade ≥3 laboratory abnormalities, Phase 2: REGN5093 Pharmacokinetics (PK), Phase 2: REGN5093 concentrations in serum over time, Phase 1 and 2: Duration of response (DOR) per RECIST 1.1., Phase 1 and 2: Disease control rate (DCR) per RECIST 1.1., Phase 1 and 2: Progression free survival (PFS) per RECIST 1.1., Phase 1 and 2: Overall survival (OS), Phase 1 and 2: Immunogenicity as measured by Anti-drug antibodies (ADA) to REGN5093
Interventions
DRUGREGN5093
Sponsors
Regeneron Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: Number of patients with Dose Limiting Toxicities, Phase 1: Incidence and severity of treatment-emergent adverse events, Phase 1: Incidence and severity of adverse events of special interest (AESIs), Phase 1: Incidence and severity of serious adverse events (SAEs), Phase 1: Incidence and severity of grade ≥3 laboratory abnormalities, Phase 1: REGN5093 concentrations in serum over time, Phase 2: Objective response rate (ORR) per RECIST 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1: ORR per RECIST 1.1, Phase 2: Incidence and severity of TEAEs, Phase 2: Incidence and severity of AESIs, Phase 2: Incidence and severity of SAEs, Phase 2: Incidence and severity of grade ≥3 laboratory abnormalities, Phase 2: REGN5093 Pharmacokinetics (PK), Phase 2: REGN5093 concentrations in serum over time, Phase 1 and 2: Duration of response (DOR) per RECIST 1.1., Phase 1 and 2: Disease control rate (DCR) per RECIST 1.1., Phase 1 and 2: Progression free survival (PFS) per RECIST 1.1., Phase 1 and 2: Overall survival (OS), Phase 1 and 2: Immunogenicity as measured by Anti-drug antibodies (ADA) to REGN5093 | — |
Countries
France
Outcome results
None listed