REGN5093 for Lung Cancer

Recruiting at 23 trial locations

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Regeneron Pharmaceuticals

Disqualifiers: Brain tumor, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

231 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have received any approved systemic therapy or participated in another study within 2 weeks before joining this trial.

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

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Dose Escalation

Determine a safe dose(s) of REGN5093 and evaluate dose-limiting toxicities

Up to 21 days

Multiple visits for dose escalation and monitoring

Phase 2: Dose Expansion

Use the REGN5093 drug dose(s) found in Phase 1 to evaluate tumor shrinkage and other outcomes

Through study completion, an average of 12 years

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• REGN5093

Trial Overview REGN5093 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

Group I: REGN5093 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School