REGN5093 for Lung Cancer

Recruiting at 22 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called REGN5093 for individuals with Non-Small Cell Lung Cancer (NSCLC) that cannot be surgically removed or has metastasized. The primary goal is to determine the safety and effectiveness of REGN5093 in shrinking tumors with a specific MET gene alteration. The trial also examines how the drug behaves in the body and identifies potential side effects. Suitable candidates for this trial have NSCLC with a MET alteration and have not recently received other cancer treatments. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that REGN5093 is likely to be safe for humans?

Research has shown that REGN5093 could be a promising treatment for lung cancer with MET alteration. Studies have found that patients generally tolerate this drug well. REGN5093 targets and breaks down a protein called MET, which aids cancer cell growth.

In earlier tests, patients experienced some side effects, mostly mild, such as tiredness, nausea, and injection site reactions. These side effects are common with many cancer treatments.

As REGN5093 remains under study, researchers closely monitor its safety. They examine how the drug acts in the body and check for any serious side effects. So far, data suggests that while REGN5093 has some side effects, they are manageable. This ongoing research aims to ensure the treatment is as safe as possible for potential trial participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

REGN5093 is unique because it specifically targets MET, a protein often overactive in certain lung cancers. This is different from standard treatments like chemotherapy, which attack rapidly dividing cells but can affect healthy cells too. Researchers are excited about REGN5093 because it offers a more precise approach, potentially leading to fewer side effects and better outcomes for patients whose tumors rely on MET signaling.

What evidence suggests that REGN5093 might be an effective treatment for lung cancer?

Research has shown that REGN5093, which participants in this trial will receive, might help people with MET-altered Non-Small Cell Lung Cancer (NSCLC). Early studies indicate that it could effectively shrink tumors. REGN5093 targets and blocks specific parts of the MET protein, which contributes to cancer growth. This action can lead to the breakdown of the MET protein, potentially slowing or stopping the cancer. Initial findings suggest that REGN5093 is generally well tolerated and has a safe profile. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. annalsofoncology.org annalsofoncology.org/article/S0923-7534(22)03147-7/fulltext

1173P Early safety, tolerability, and efficacy of REGN5093 ... These early results suggest REGN5093 may have a therapeutic benefit in pts with MET-altered NSCLC and showed promising efficacy signals with an acceptable ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04077099

NCT04077099 | A Study of REGN5093 in Adult Patients ... This study will evaluate REGN5093 for the treatment of Non-Small Cell Lung Cancer (NSCLC) with MET alteration.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.TPS9628

A phase I/II study of REGN5093, a MET x MET bispecific ... REGN5093 is a human bispecific antibody that binds to two distinct epitopes of MET, blocking HGF binding and inducing internalization and degradation of MET.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11384497/

REGN5093-M114: can an antibody-drug conjugate ... The results showed that REGN5093-M114 reduced cell viability and was more effective ... non-small cell lung cancer from the AURA3 trial. Nat ...

5. withpower.com withpower.com/trial/phase-2-7-2021-cd031

REGN5093-M114 for Non-Small Cell Lung Cancer In a study with monkeys, REGN5093-M114 was well tolerated at doses that were effective in reducing tumors in mice, suggesting it may be safe for humans, but ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04982224

NCT04982224 | Study of REGN5093-M114 (METxMET ... This study is researching an experimental drug called REGN5093-M114 by itself and in combination with cemiplimab. The study is focused on advanced non-small ...