The primary objective of the dose escalation (phase 1) part of the study is:
• To assess the safety, tolerability and pharmacokinetics (PK) of the antibody drug conjugate (ADC) REGN5093-M114 in order to determine a maximum tolerated dose (MTD) and/or define the recommended phase 2 dose (RP2D) of REGN5093-M114 in patients with mesenchymal epithelial transition factor (MET) overexpressing 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-M114 in MET-overexpressed NSCLC as measured by the objective response rate (ORR)
The secondary objective of the dose escalation (phase 1) part of the study is:
• To assess preliminary anti-tumor activity of REGN5093-M114 as measured by the ORR
The secondary objective of the dose expansion (phase 2) part of the study is:
• To assess the safety, tolerability profile, and PK of REGN5093-M114 ADC and total antibody in each expansion cohort
The secondary objectives of both phases of the study are:
- To evaluate other measures of preliminary anti-tumor activity
- To assess immunogenicity to REGN5093-M114
A Phase 1/2 Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Patients With MET Overexpressing Advanced Cancer