MGY825 for Lung Cancer

Recruiting at20 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Novartis Pharmaceuticals

Must be taking: Platinum-based, PD-(L)1, targeted drugs

Disqualifiers: Heart disease, CNS metastases, COVID-19, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called MGY825 in adult patients with advanced lung cancer. It focuses on those with certain genetic mutations to see if the drug is safe and effective in shrinking tumors.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that prior therapy with certain drugs is allowed, so it's best to discuss your specific medications with the trial team.

Research Team

Eligibility Criteria

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.

Inclusion 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.

Exclusion Criteria

I have brain metastases that are stable and I'm on a low dose of steroids.

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.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Investigation of the safety and tolerability of MGY825 in patients with specific mutations

28 days

Multiple visits (in-person)

Dose Expansion

Assessment of preliminary anti-tumor activity and further safety evaluation of MGY825

28 months

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MGY825 (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Dose expansion group 2 Experimental Treatment 1 Intervention

Patients with advanced NSCLC irrespective of prior knowledge of NFE2L2/KEAP1/CUL3 mutational status.

Group II: Dose expansion group 1 Experimental Treatment 1 Intervention

Patients with advanced NSCLC harboring NFE2L2/KEAP1/CUL3 mutations enrolled based on locally available test results of mutation status

Group III: Dose escalation Experimental Treatment 1 Intervention

Patients with advanced NSCLC harboring NFE2L2/KEAP1/CUL3 mutations enrolled based on locally available test results of mutation status

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD