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Monoclonal Antibodies
MGY825 for Lung Cancer
Phase 1
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with histologically or cytologically confirmed diagnosis of advanced (metastatic or unresectable) NFE2L2/KEAP1/CUL3 mutant NSCLC. Local data confirming the NFE2L2/KEAP1/CUL3 mutation status in tissue must be available for enrollment.
Patients must have progressed after 1 platinum-based chemotherapy regimen and PD-(L)1 antibody therapy either sequentially or concurrent with chemotherapy, where indicated, for Stage IV NSCLC.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 months
Awards & highlights
Study Summary
This trialstudied if a single drug could help treat advanced lung cancer in adults.
Who is the study for?
Adults with advanced non-small cell lung cancer who've had one platinum-based chemo and PD-(L)1 therapy, but the cancer has progressed. They must be able to undergo a biopsy, have certain mutations (NFE2L2/KEAP1/CUL3), and measurable lesions. Excluded if they have serious heart issues, uncontrolled blood pressure, recent heart attack or angina, can't swallow capsules, untreated brain metastases requiring steroids or treatment within 4 weeks before the trial.Check my eligibility
What is being tested?
The study is testing MGY825 as a single agent in patients with advanced non-small cell lung cancer. Participants will receive this experimental medication to see how effective it is against their cancer after previous treatments have failed.See study design
What are the potential side effects?
While specific side effects of MGY825 are not listed here, common side effects for similar treatments may include fatigue, nausea, diarrhea, skin reactions and potential liver enzyme elevations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is advanced, cannot be surgically removed, and has specific genetic mutations.
Select...
My Stage IV NSCLC worsened after platinum-based chemo and PD-(L)1 therapy.
Select...
My lung cancer is advanced and cannot be removed by surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose intensity
Frequency of dose interruptions and reductions
Incidence and nature of dose limiting toxicities (DLTs) during the first 28 days of treatment with the study drug
+1 moreSecondary outcome measures
Area under the concentration-time curve (AUC)
Duration of response (DOR) per RECIST 1.1
Heart rate
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Dose expansion group 2Experimental Treatment1 Intervention
Patients with advanced NSCLC irrespective of prior knowledge of NFE2L2/KEAP1/CUL3 mutational status.
Group II: Dose expansion group 1Experimental Treatment1 Intervention
Patients with advanced NSCLC harboring NFE2L2/KEAP1/CUL3 mutations enrolled based on locally available test results of mutation status
Group III: Dose escalationExperimental Treatment1 Intervention
Patients with advanced NSCLC harboring NFE2L2/KEAP1/CUL3 mutations enrolled based on locally available test results of mutation status
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,198,104 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have at least one visible and measurable abnormality according to specific guidelines.I am willing and able to have a biopsy of my cancer according to my hospital's rules.My lung cancer is advanced, cannot be surgically removed, and has specific genetic mutations.I had platinum-based therapy and my condition worsened within 6 months.I have brain metastases that are stable and I'm on a low dose of steroids.My Stage IV NSCLC worsened after platinum-based chemo and PD-(L)1 therapy.I have had treatments targeting blood vessel growth and must have had specific targeted therapies if my lung cancer has certain mutations.I do not have serious heart conditions like uncontrolled high blood pressure or heart failure.Your kidneys are not working well (based on a specific calculation) and your blood has high levels of certain substances. Your liver function is not within the normal range, and certain blood cell counts are too low.I have a heart condition with a long QT interval or had a recent heart attack.My lung cancer is advanced and cannot be removed by surgery.I cannot or do not want to take pills as required.I currently have an active COVID-19 infection.
Research Study Groups:
This trial has the following groups:- Group 1: Dose expansion group 2
- Group 2: Dose escalation
- Group 3: Dose expansion group 1
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.
What is the participation rate of this investigation?
"Affirmative, the details hosted on clinicaltrials.gov declare that this scientific trial is currently finding participants. This research was originally posted on October 5th 2022 and revised for accuracy most recently on December 1st 2022. The protocol seeks enrolment of 140 people across a single site."
Answered by AI
Is there still opportunity for volunteers to join this experiment?
"Affirmative. Per analysis from clinicaltrials.gov, this medical trial is still recruiting patients since it was first posted on October 5th 2022 and last updated on December 1st 2022. It requires 140 individuals to be recruited at a single research location."
Answered by AI
Is the Dose Expansion Group 2 protocol safe for patient participants?
"Due to the limited data present at this Phase 1 trial, it is estimated that Dose Expansion Group 2 has a safety rating of 1."
Answered by AI
What is the intended outcome of this trial?
"This trial, which spans almost two and a half years, aims to assess the frequency of dosage adjustments. Secondary objectives include evaluating preliminary anti-tumor activity with RECIST 1.1 criteria, measuring progression free survival (PFS) per RECIST 1.1 standards, and calculating pharmacokinetic parameters using non-compartmental methods for maximum drug concentrations in systemic circulation (Tmax)."
Answered by AI
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