REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer
- Registration Number
- NCT04077099
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 82
- Histologically confirmed NSCLC that is at advanced stage. Advanced is defined as unresectable or metastatic disease. Patients must have exhausted all approved available therapies appropriate for the patient.
- Has available archival tumor tissue, unless discussed with the medical monitor.
- Willing to provide tumor tissue from newly obtained biopsy. Newly obtained biopsies at screening are required unless medically contra-indicated and discussed with the medical monitor. For patients in expansion cohorts, biopsies should be taken from tumor site which has not been irradiated previously and is not the only measurable target lesion.
- Previously documented presence of MET alterations: either MET-exon14 gene mutation and/or MET gene amplification, and/or elevated MET protein expression, as defined in the protocol.
Key
- Has received treatment with an approved systemic therapy or has participated in any study of an investigational agent or investigational device 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
- Has not yet recovered (i.e. grade ≤1 or baseline) from any acute toxicities resulting from prior therapy except as described in the protocol
- Has received radiation therapy or major surgery within 14 days of first administration of study drug or has not recovered (i.e. grade ≤1 or baseline) from AEs, except for laboratory changes as described in the protocol and patients with grade ≤2 neuropathy
- For expansion cohorts only: prior treatment with MET-targeted biologic therapy (function-blocking antibodies or ADCs)
- For expansion cohorts only (except cohort 1A) prior treatment with any MET-targeted agent including small molecule tyrosine kinase inhibitors eg, crizotinib, capmatinib, tepotinib, as defined in the protocol
- Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease or spinal cord compression as defined in the protocol
Note: Other protocol defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description REGN5093 REGN5093 Monotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2)
- Primary Outcome Measures
Name Time Method 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
REGN5093 concentrations in serum over time 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
Objective response rate (ORR) per RECIST 1.1 Through study completion, an average of 12 years Phase 2/Dose expansion
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Regeneron Research Facility
🇰🇷Seoul, Korea, Republic of
Regeneron Study Site
🇫🇷Caen cedex, France