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Antibody-Drug Conjugate
REGN5093-M114 for Non-Small Cell Lung Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment to see if it is safe and effective. The treatment is an antibody drug conjugate called REGN5093-M114 and it is being tested on patients with a certain type of lung cancer. The study has two parts, or phases. The first phase is to see if the treatment is safe and to find the best dose. The second phase is to see if the treatment works against the cancer.
Who is the study for?
Adults with advanced non-small cell lung cancer (NSCLC) that overexpresses MET protein. Participants must be in good physical condition (ECOG 0 or 1), have proper organ and bone marrow function, and provide a recent tumor tissue sample. Those who've had certain treatments or surgeries recently, active brain tumors, uncontrolled infections like HIV/Hepatitis B/C, or other progressing cancers aren't eligible.Check my eligibility
What is being tested?
The trial is testing REGN5093-M114, an antibody-drug conjugate targeting MET-overexpressing cancer cells. Phase 1 determines the safest dose with acceptable side effects; phase 2 tests how well it works against NSCLC by measuring tumor response rates.See study design
What are the potential side effects?
Potential side effects of REGN5093-M114 may include reactions at the infusion site, changes in blood counts leading to increased infection risk or bleeding problems, liver issues, fatigue, nausea and potential allergic responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicities (DLTs)
Laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE])
Objective response rate (ORR)
+2 moreSecondary outcome measures
Concentrations of M24 in plasma
Concentrations of REGN5093-M114 in serum
Concentrations of cemiplimab when given in combination with REGN5093-M114
+18 moreSide effects data
From 2023 Phase 3 trial • 608 Patients • NCT0325726725%
Anaemia
20%
Nausea
17%
Fatigue
16%
Vomiting
15%
Decreased appetite
15%
Constipation
11%
Asthenia
11%
Back pain
11%
Pyrexia
11%
Diarrhoea
10%
Arthralgia
9%
Urinary tract infection
9%
Dyspnoea
9%
Abdominal pain
7%
Cough
7%
Oedema peripheral
7%
Hypoalbuminaemia
7%
Headache
6%
Pain in extremity
6%
Rash
6%
Blood creatinine increased
6%
Insomnia
6%
Hypokalaemia
6%
Hypothyroidism
5%
Pruritus
5%
Vaginal haemorrhage
4%
Alanine aminotransferase increased
4%
Aspartate aminotransferase increased
4%
Pelvic pain
4%
Stomatitis
3%
Neutropenia
2%
Acute kidney injury
1%
Immune-mediated hepatitis
1%
Autoimmune hepatitis
1%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
1%
Thrombocytopenia
1%
Neutrophil count decreased
1%
Pyelonephritis acute
1%
White blood cell count decreased
1%
Sepsis
1%
Duodenal ulcer
1%
Haematuria
1%
Hydronephrosis
1%
Hyperpyrexia
1%
Kidney infection
1%
Pneumonitis
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cemiplimab
Investigator Choice (IC) Chemotherapy
Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase 2. Dose ExpansionExperimental Treatment2 Interventions
Cohorts A and B: REGN5093-M114 monotherapy. Cohort C: REGN5093-M114+cemiplimab combination.
Group II: Phase 1. Dose EscalationExperimental Treatment2 Interventions
Cohorts A and B: REGN5093-M114 monotherapy. Cohort C: REGN5093-M114+cemiplimab combination.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsLead Sponsor
620 Previous Clinical Trials
380,148 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
262 Previous Clinical Trials
250,957 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any cancer treatment or been in a trial for at least 2 weeks.I do not have an active brain tumor or cancer spread to my brain or spinal cord.I am willing to provide a recent or new biopsy of my tumor for testing.I haven't had major surgery or radiation within the last 14 days and have recovered from any side effects.I do not have another cancer that is getting worse or needs treatment.I haven't had brain inflammation, serious brain disorders, or uncontrolled seizures in the last year.My lung cancer is at an advanced stage with no other beneficial treatments available.I have at least one tumor that can be measured and has grown after radiation.My tumor has high levels of MET protein.My organs and bone marrow are functioning well.I am fully active or restricted in physically strenuous activity but can do light work.I have mostly recovered from side effects of my previous treatments.I do not have an uncontrolled HIV, hepatitis B or C, or a diagnosed immunodeficiency.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2. Dose Expansion
- Group 2: Phase 1. Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
From how many different places is this clinical trial being overseen?
"There are many hospitals enrolling patients in this clinical trial, such as John Hopkins in Baltimore, Henry Ford Hospital in Charleston, and Medical University of South carolina in New york. In total, there are 10 locations running this study."
Answered by AI
What are researchers trying to find out by conducting this trial?
"The main goal of this clinical trial, which will take an average of 2 years to complete, is to monitor serious adverse events. Additionally, the study hopes to assess the duration of response in phase 1 and phase 2 patients as well as total monoclonal antibodies in serum (REGN5093-M114 plus unconjugated antibody) during dose expansion (phase 2). Another objective is to understand REGN5093-M114 concentrations in serum during dose expansion (Phase 2)."
Answered by AI
Are we presently recruiting participants for this research project?
"Yes, the study is still recruiting patients. The listing on clinicaltrials.gov shows that it was first posted on November 9th 2021 and updated as recently as October 19th 2022. They are hoping to recruit 83 individuals from 10 different centres."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
What site did they apply to?
Johns Hopkins Satellite Site
What portion of applicants met pre-screening criteria?
Met criteria
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