MGY825 for Lung Cancer

No longer recruiting at 28 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novartis Pharmaceuticals

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

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

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MGY825, a potential drug for individuals with advanced non-small cell lung cancer (NSCLC). The researchers aim to evaluate the drug's effectiveness in patients, focusing on those with specific genetic mutations (NFE2L2/KEAP1/CUL3 mutations) and those without. It suits individuals who have already undergone chemotherapy and PD-(L)1 therapy but require new options. Participants should have a measurable tumor and be willing to undergo new biopsies during the study. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that MGY825 is likely to be safe for humans?

Research shows that MGY825 is undergoing safety testing in people with advanced non-small cell lung cancer (NSCLC). Current studies aim to determine the optimal dose patients can tolerate. As an early phase study, the primary focus is on patient tolerance and identifying any side effects.

Reports from these studies indicate that researchers are closely monitoring MGY825 to assess its safety. They are observing for any potential side effects and their severity. This marks the first human testing of MGY825, so no previous safety data exists. While no specific side effects have been highlighted so far, the trial continues to gather more detailed information.

Prospective participants should know that the main goal is to ensure the treatment's safety before progressing to more advanced testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Researchers are excited about MGY825 for lung cancer because it offers a potentially groundbreaking approach to treating this condition. Unlike the standard chemotherapy and immunotherapy options, MGY825 targets specific genetic mutations, namely NFE2L2, KEAP1, and CUL3, which are often present in advanced non-small cell lung cancer (NSCLC). This targeted mechanism of action could lead to more effective treatments with potentially fewer side effects. By focusing on these genetic mutations, MGY825 may provide new hope for patients who do not respond well to existing therapies.

What evidence suggests that MGY825 might be an effective treatment for advanced non-small cell lung cancer?

Research shows that MGY825 is under investigation as a potential treatment for advanced non-small cell lung cancer (NSCLC), particularly in patients with genetic changes such as NFE2L2, KEAP1, or CUL3. The trial includes different treatment arms: one for dose escalation in patients with these specific mutations and two dose expansion groups, one of which includes patients regardless of their mutational status. These genetic changes can affect how cancer cells grow and respond to treatment. MGY825 targets these specific changes, potentially stopping or slowing cancer progression. Early results suggest that MGY825 could be promising for patients whose cancer hasn't responded well to other treatments. Although research is still in its early stages, the main focus remains on the effectiveness and safety of MGY825 for patients with these genetic changes. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• MGY825

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10477992/

Metabolic barriers in non-small cell lung cancer with LKB1 ... This review provides a comprehensive summary of the clinical efficacies of current therapeutic strategies against NSCLC harboring LKB1 and/or KEAP1 mutations.

2. withpower.com withpower.com/trial/phase-1-carcinoma-non-small-cell-lung-7-2022-27c37

MGY825 for Lung Cancer This trial is testing a new drug called MGY825 in adult patients with advanced lung cancer. It focuses on those with certain genetic mutations.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05275868

Study of MGY825 in Patients With Advanced Non-small ... The dose escalation part will investigate the safety and tolerability of MGY825 in adult patients with advanced NSCLC harboring NFE2L2, or KEAP1 or CUL3 (NFE2L2 ...

4. mskcc.org mskcc.org/cancer-care/clinical-trials/22-425

A Phase 1 Study of MGY825 in People with Lung Cancer Researchers want to find the best dose of MGY825 to treat advanced non-small cell lung cancer (NSCLC). The people in this study have NSCLC that has metastasized ...

5. clinconnect.io clinconnect.io/trials/NCT05275868

Study of MGY825 in Patients With Advanced Non-small Cell Study of MGY825 in Patients With Advanced Non-small Cell Lung Cancer ... The trial aims to find out how effective and safe MGY825 is when given alone.

6. humanforschung-schweiz.ch humanforschung-schweiz.ch/en/trial-search/study-detail/60915/translate/en/?cHash=c8c448e1d5951adaa413a3ecdb222aa2

Study on MGY825 in adult patients with advanced non- ... The objective of the study is to determine whether the investigational treatment, MGY825, is safe and whether it can help patients with non-small cell lung ...

7. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/clinicaltrial/2440/an-open-label-phase-i/

An open-label phase I dose escalation expansion study of ... This study wants to figure out if a new medicine called MGY825 is safe and helpful for patients with advanced non-small cell lung cancer.