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).
Histologically confirmed NSCLC that is at advanced stage. Advanced is defined as unresectable or metastatic disease. > Patients must have exhausted all approved available therapies.
Has available archival tumor tissue
Willing to provide tumor tissue from newly obtained biopsy from tumor site which has not been irradiated previously and is not the only measurable lesion. Newly obtained biopsies at screening are required unless discussed with the medical monitor.
Provision of archival tumor tissue is mandated.
Previously documented presence of MET alterations: either MET-exon14 gene mutation and/or MET gene amplification, and/or elevated MET protein expression
ECOG performance status of 0 or 1
Adequate organ and bone marrow function as outlined per protocol.
Adult patients 18 years of age or older
Willing and able to comply with clinic visits and study-related procedures and requirements
Has received treatment with an approved systemic therapy or has participated in any study of an investigational agent or investigational device according to the following timeframe: For small molecule cytotoxins or other agents unlikely to interact with study drug: within 2 weeks or 5 half-lives of the prior treatment whichever is shorter with a minimum of 7 days from the first dose of study therapy.Exception: Patients who have received or are enrolled in a study involving treatment with an investigational immunoPET reagent are not excluded.
Has not yet recovered from any acute toxicities resulting from prior therapy except for laboratory changes as described in inclusiion criteria and patients with grade 2 or less neuropathy.
Has received radiation therapy or major surgery within 14 days of first administration of study drug or has not recovered (i.e. > For expansion cohorts only: prior treatment with MET-targeted biologic therapy
For expansion cohorts only: Another malignancy, with the following exceptions: a. Non-melanoma skin cancer that has undergone potentially curative therapy or b. In situ cervical carcinoma or c. Any other tumor that has been treated, and the patient is deemed is be in complete remission for at least 2 years prior to enrollment and no additional therapy is required during the study period
Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease or spinal cord compression as defined in the protocol
Encephalitis, meningitis, organic brain disease (e.g.Parkinsons disease) or uncontrolled seizures in the year prior to first dose of study therapy.
Uncontrolled infection with human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency
Known allergy to doxycycline or other tetracycline antibiotics
Note: Other protocol defined Inclusion/Exclusion criteria apply.
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