Single-arm Study With Bimiralisib in Patients With HNSCC Harboring NOTCH1 Loss of Function Mutations

Exclusion Criteria

• •1. Has received any anti-cancer treatment including hormonal and investigational agents within 21 days prior to first dose of bimiralisib.
• •2. Major surgery within 28 days prior to first dose of bimiralisib or persisting side effects that have not improved to NCI-CTCAE grade 1 or better.
• •3. Pregnant or nursing (lactating) women.
• •4. Poorly controlled diabetes mellitus, steroid-induced diabetes mellitus
• •5. Has other active malignancies that require systemic treatment.
• •6. Has a known history of HIV infection
• •7. Any of the following cardiac abnormalities:
• •* History of, or current, documented congestive heart failure (New York heart association functional classification iii - iv), documented cardiomyopathy
• •* Symptomatic (NYHA class II or higher) left ventricular ejection fraction (LVEF) \< 40% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (echo)
• •* Myocardial infarction ≤ 6 months prior to enrolment
• •* Unstable angina pectoris
• •* Serious uncontrolled cardiac arrhythmia
• •* Symptomatic pericarditis
• •8. Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
• •9. Patient has a history of non-compliance to medical regimen or inability to grant consent.
• •10. Medically documented history of an active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) or ≥ CTCAE grade 3 anxiety
• •11. History of interstitial pneumonitis or patients who require chronic oxygen supplementation.