REGN5093 for Lung Cancer

Recruiting in Palo Alto (17 mi)

+23 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Regeneron Pharmaceuticals

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will evaluate REGN5093 for the treatment of Non-Small Cell Lung Cancer (NSCLC) with MET alteration. The main purpose of this study is to determine the safety, tolerability, and effectiveness of REGN5093. The study has two phases. The main goal of Phase 1 is to determine a safe dose(s) of REGN5093. The main goal of phase 2 of the study is to use the REGN5093 drug dose(s) found in Phase 1 to see how well REGN5093 works to shrink tumors. The study is looking at several other research questions, including: * Side effects that may be experienced by people taking REGN5093 * How REGN5093 works in the body * How much REGN5093 is present in the blood * To see if REGN5093 works to reduce or delay the progression of cancer * How long it takes REGN5093 to work in the body

Eligibility Criteria

This trial is for patients with advanced Non-Small Cell Lung Cancer who have MET alterations and have tried all other approved treatments. They must provide tumor tissue samples, not have had recent radiation or major surgery, and should not be recovering from severe side effects of previous therapies.

Inclusion Criteria

My lung cancer is at an advanced stage and cannot be removed by surgery.

I have tried all approved treatments for my condition.

I am willing to provide a new biopsy sample for the study.

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Exclusion Criteria

I have previously received MET-targeted therapy.

I have previously been treated with a MET-targeted agent, except if I'm in cohort 1A.

I still have side effects from previous treatments, but they are mild.

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Treatment Details

Interventions

REGN5093 (Monoclonal Antibodies)

Trial OverviewREGN5093 is being tested to determine its safety (phase 1) and how well it works against lung cancer (phase 2). The study will find the highest dose patients can take without serious side effects and measure the drug's effect on tumor size.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: REGN5093Experimental Treatment1 Intervention

Monotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2)