An open-label, phase I, dose escalation, expansion study of MGY825 in adult patients with advanced non-small cell lung cancer

Yamauchi Kyosuke0 sites12 target enrollmentAugust 19, 2022

Conditionsadvanced non-small cell lung cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: advanced non-small cell lung cancer
Sponsor: Yamauchi Kyosuke
Enrollment: 12
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 19, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Yamauchi Kyosuke

Eligibility Criteria

Inclusion Criteria

•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/or PD\-(L)1 antibody therapy, where indicated, for Stage IV NSCLC Prior therapy with VEGF/VEGFR targeting agents is permitted Prior neo\-adjuvant / adjuvant therapy 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 Criteria

•Having out of range laboratory values defined as:
•Creatinine clearance (calculated using Cockcroft\-Gault formula, or measured) \< 40 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.