Non-small Cell Lung CancerPhase 1NCT05275868
Study of MGY825 in Patients With Advanced Non-small Cell Lung Cancer
A Phase 1 study testing MGY825 in people with Non-small Cell Lung Cancer, run by Novartis Pharmaceuticals at 15 sites in 6 countries.
Trial summary
Study of MGY825 single agent in adult patients with advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- MGY825
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 5 Oct 2022to 13 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be obtained prior to participation in the study.
- Dose escalation and dose expansion group 1:
- 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.
- Dose expansion group 2:
- Patients with histologically or cytologically confirmed diagnosis of advanced (metastatic or unresectable) NSCLC irrespective of NFE2L2/KEAP1/CUL3 mutation status.
- All patients:
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- 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.
- Patients treated with neo-adjuvant / adjuvant platinum-based therapy that progressed within 6 months of treatment are permitted to participate.
- Prior therapy with VEGF/VEGFR targeting agents is permitted. Prior treatment with approved targeted drugs (e.g., EGFRi, ALKi, METi) is mandatory in patients with NSCLC whose tumor bears actionable mutations.
- Presence of at least one measurable lesion according to RECIST v1.1.
- Patient must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening and during study treatment. A recent biopsy collected after the last systemic treatment and within 3 months before study entry may be submitted at screening.
Who cannot join
- Having out of range laboratory values defined as:
- Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min Total bilirubin > 1.5 x ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN ALT > 3 x ULN AST > 3 x ULN ANC < 1.0 x 109/L Platelet count < 75 x 109/L Hemoglobin < 9 g/dL
- Impaired cardiac function or clinically significant cardiac disease, including any of the following:
- Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade ≥2), uncontrolled hypertension or clinically significant arrhythmia.
- QTcF > 470 msec on screening ECG or congenital long QT syndrome. Acute myocardial infarction or unstable angina pectoris < 3 months prior to study entry.
- Presence of symptomatic CNS metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery) or increasing doses of corticosteroids within 2 weeks prior to study entry. Patients with treated symptomatic brain metastases should be neurologically stable (for 4 weeks post-treatment and prior to study entry) and at a dose of ≤ 10 mg per day prednisone or equivalent for at least 2 weeks before administration of any study treatment.
- Known active COVID-19 infection.
- Unable or unwilling to swallow capsules as per dosing schedule. Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
United States7 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, 77030
NYU School of Medicine
New York, New York, 10015
Memorial Sloan Kettering Onc. Dept
New York, New York, 10017
Memorial Sloan Kettering
New York, New York, 10017
Wash U School of Medicine
St Louis, Missouri, 63110
Germany3 sites
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Frankfurt am Main, Hesse, 60590
Switzerland2 sites
Novartis Investigative Site
Geneva, CH 1211
Novartis Investigative Site
Sankt Gallen, 9007
About this study
Official title: An Open-label, Phase I, Dose Escalation, Expansion Study of MGY825 in Adult Patients With Advanced Non-small Cell Lung Cancer
Study of MGY825 single agent in adult patients with advanced non-small cell lung cancer.
Read the detailed description
First in human, phase I, multicenter, open-label study of MGY825 single agent with a dose escalation and a dose expansion in adult patients with advanced non-small cell lung cancer (NSCLC).
The dose escalation part investigated the safety and tolerability of MGY825 in adult patients with advanced NSCLC harboring NFE2L2, or KEAP1 or CUL3 (NFE2L2/KEAP1/CUL3) mutations. Patient enrollment was based on locally available test results of mutation status.
An exploratory assessment on the effect of food could be investigated during the dose escalation part.
The dose expansion part assessed the preliminary anti-tumor activity and further assess the safety and tolerability of MGY825 in adult patients with advanced NSCLC divided in two patient groups.
Group 1: Patients with advanced NSCLC harboring NFE2L2/KEAP1/CUL3 mutations enrolled based on locally available test results of mutation status.
Group 2: Patients with advanced NSCLC irrespective of prior knowledge of NFE2L2/KEAP1/CUL3 mutational status.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- MGY825
- Keywords
- non-small cell lung cancer (NSCLC), NFE2L2, NRF2, KEAP1, CUL3, MGY825
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGY825Drug
investigational drug
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | Patients with advanced NSCLC harboring NFE2L2/KEAP1/CUL3 mutations enrolled based on locally available test results of mutation status Receives: Drug: MGY825 |
| Dose expansion group 1 | Experimental | Patients with advanced NSCLC harboring NFE2L2/KEAP1/CUL3 mutations enrolled based on locally available test results of mutation status Receives: Drug: MGY825 |
| Dose expansion group 2 | Experimental | Patients with advanced NSCLC irrespective of prior knowledge of NFE2L2/KEAP1/CUL3 mutational status. Receives: Drug: MGY825 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Assessment of safety of study drug as a single agent
Measured: 28 months
Frequency of dose interruptions and reductions
Assessment of tolerability of study drug as a single agent
Measured: 28 months
Dose intensity
Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of exposure.
Measured: 28 months
Incidence and nature of dose limiting toxicities (DLTs) during the first 28 days of treatment with the study drug
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 assessed as not primarily related to disease, disease progression, inter-current illness or concomitant medications that occurs during the first 28 days of treatment with the study drug. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Measured: 28 days
Secondary outcomes (6)
Area under the concentration-time curve (AUC)
Pharmacokinetics (PK) parameters will be determined by non-compartmental methods using the PK profile of the study drug.
Measured: 20 months
Peak concentration (Cmax)
Pharmacokinetics (PK) parameters will be determined by non-compartmental methods using the PK profile of the study drug.
Measured: 20 months
Time to reach maximum drug concentrations in systemic circulation (Tmax)
Pharmacokinetics (PK) parameters will be determined by non-compartmental methods using the PK profile of the study drug.
Measured: 20 months
Overall response rate (ORR) per RECIST 1.1
Evaluation of preliminary anti-tumor activity of study drug as single agent
Measured: 28 months
Progression free survival (PFS) per RECIST 1.1
Evaluation of preliminary anti-tumor activity of study drug as single agent
Measured: 28 months
Duration of response (DOR) per RECIST 1.1
Evaluation of preliminary anti-tumor activity of study drug as single agent
Measured: 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start5 Oct 2022
- Primary completion13 Oct 2025
- Study completion13 Oct 2025
Why it stopped: The trial was terminated due to a business decision and not as a result of any safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275868
- Sponsor's protocol ID
- CMGY825A12101
- Other IDs
- 2023-504350-36-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 24 Feb 2022
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I, Dose Escalation, Expansion Study of MGY825 in Adult Patients With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05275868
- Acronym / sponsor ID
- CMGY825A12101
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- non-small cell lung cancer (NSCLC), NFE2L2, NRF2, KEAP1, CUL3, MGY825
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated due to a business decision and not as a result of any safety concerns
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 13 Oct 2025 (actual)
- Study completion
- 13 Oct 2025 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of MGY825 single agent in adult patients with advanced non-small cell lung cancer.
Detailed description
First in human, phase I, multicenter, open-label study of MGY825 single agent with a dose escalation and a dose expansion in adult patients with advanced non-small cell lung cancer (NSCLC).
The dose escalation part investigated the safety and tolerability of MGY825 in adult patients with advanced NSCLC harboring NFE2L2, or KEAP1 or CUL3 (NFE2L2/KEAP1/CUL3) mutations. Patient enrollment was based on locally available test results of mutation status.
An exploratory assessment on the effect of food could be investigated during the dose escalation part.
The dose expansion part assessed the preliminary anti-tumor activity and further assess the safety and tolerability of MGY825 in adult patients with advanced NSCLC divided in two patient groups.
Group 1: Patients with advanced NSCLC harboring NFE2L2/KEAP1/CUL3 mutations enrolled based on locally available test results of mutation status.
Group 2: Patients with advanced NSCLC irrespective of prior knowledge of NFE2L2/KEAP1/CUL3 mutational status.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: MGY825Patients with advanced NSCLC harboring NFE2L2/KEAP1/CUL3 mutations enrolled based on locally available test results of mutation status |
| Dose expansion group 1 | Experimental | Drug: MGY825Patients with advanced NSCLC harboring NFE2L2/KEAP1/CUL3 mutations enrolled based on locally available test results of mutation status |
| Dose expansion group 2 | Experimental | Drug: MGY825Patients with advanced NSCLC irrespective of prior knowledge of NFE2L2/KEAP1/CUL3 mutational status. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent must be obtained prior to participation in the study.
- Dose escalation and dose expansion group 1:
- 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.
- Dose expansion group 2:
- Patients with histologically or cytologically confirmed diagnosis of advanced (metastatic or unresectable) NSCLC irrespective of NFE2L2/KEAP1/CUL3 mutation status.
Key exclusion criteria (8 listed)
- Having out of range laboratory values defined as:
- Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min Total bilirubin > 1.5 x ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN ALT > 3 x ULN AST > 3 x ULN ANC < 1.0 x 109/L Platelet count < 75 x 109/L Hemoglobin < 9 g/dL
- Impaired cardiac function or clinically significant cardiac disease, including any of the following:
- Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade ≥2), uncontrolled hypertension or clinically significant arrhythmia.
- QTcF > 470 msec on screening ECG or congenital long QT syndrome. Acute myocardial infarction or unstable angina pectoris < 3 months prior to study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGY825investigational drug | Drug | Dose escalation, Dose expansion group 1, Dose expansion group 2 |
Primary outcome
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 28 months
Assessment of safety of study drug as a single agent
Frequency of dose interruptions and reductions
Time frame: 28 months
Assessment of tolerability of study drug as a single agent
Dose intensity
Time frame: 28 months
Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of exposure.
Incidence and nature of dose limiting toxicities (DLTs) during the first 28 days of treatment with the study drug
Time frame: 28 days
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 assessed as not primarily related to disease, disease progression, inter-current illness or concomitant medications that occurs during the first 28 days of treatment with the study drug. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
6 secondary outcomes
Area under the concentration-time curve (AUC)
Time frame: 20 months
Peak concentration (Cmax)
Time frame: 20 months
Time to reach maximum drug concentrations in systemic circulation (Tmax)
Time frame: 20 months
Overall response rate (ORR) per RECIST 1.1
Time frame: 28 months
Progression free survival (PFS) per RECIST 1.1
Time frame: 28 months
Duration of response (DOR) per RECIST 1.1
Time frame: 28 months
Results and safety
The study was stopped early (reason given: The trial was terminated due to a business decision and not as a result of any safety concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Link to Study ResultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MGY825 in people with Non-small Cell Lung Cancer, run by Novartis Pharmaceuticals at 15 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Germany, Switzerland, Japan, South Korea and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The trial was terminated due to a business decision and not as a result of any safety concerns). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (time frame: 28 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.