Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT04077099
Phase: Phase I/II
Principal Investigator: Gray, Jhanelle
A Phase 1/2 Study of REGN5093 in Patients with Met-Altered Advanced Non-Small Cell Lung Cancer
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)
Primary Objective for Phase 1 part of study: 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 NSCLC. Primary Objective of Phase 2 part of study: 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). Secondary Objective for Phase 1 part of the study: To assess preliminary anti-tumor activity of REGN5093 as measured by the ORR per RECIST 1.1. Secondary Objectives for Phase 2 part of study: To assess the safety and tolerability of REGN5093 in each expansion cohort. To assess REGN5093 PK and concentrations in serum. Secondary Objectives of both parts of the study: To assess immunogenicity as measured by anti-drug antibodies (ADA) to REGN5093. To evaluate other measures of preliminary anti-tumor activity. Exploratory Objectives of Phase 2 part of study: To evaluate relationships between efficacy of REGN5093 and baseline MET alteration/mutation or amplification/expression. To assess pharmacodynamic changes in putative serum or plasma biomarkers. To evaluate the impact on efficacy of tumor mutational spectrum at baseline and post-treatment in tissue and in circulating tumor DNA (ctDNA).
Therapy (NOS)
REGN5093 ()
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