Status:
TERMINATED
Study of MGY825 in Patients With Advanced Non-small Cell Lung Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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:
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2025
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT05275868
Start Date
October 5 2022
End Date
October 13 2025
Last Update
November 10 2025
Active Locations (15)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Wash U School of Medicine
St Louis, Missouri, United States, 63110
4
NYU School of Medicine
New York, New York, United States, 10015