Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors

Inclusion Criteria

• Able to understand and voluntarily sign the ICF and able to comply with the study visit schedule and the other protocol requirements.
• Patient (male or female) ≥18 years of age willing to agree to not father a child/become pregnant and comply with effective contraception criteria.
• Must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or is appropriate.
• ECOG (Eastern cooperative oncology group) performance status ≤2 Additional criteria only appying to TNO155 in combination with EGF816 (nazartinib):
• Patients must be screened for Hepatitis B virus and Hepatitis C virus

Exclusion Criteria

• Tumors harboring known activating KRAS, NRAS, HRAS, BRAF or PTPN11 (SHP2) mutations. (Exceptions are KRAS G12-mutant NSCLC's)
• History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
• Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
• Clinically significant cardiac disease.
• Active diarrhea or inflammatory bowel disease
• Insufficient bone marrow function
• Insufficient hepatic and renal function. Additional criteria only appying to TNO155 in combination with EGF816 (nazartinib):
• Patients with a known history of human immunodeficiency virus (HIV) seropositivity.
• Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use at the time of study entry.
• Patients who have undergone a bone marrow or solid organ transplant
• Patients with a history or presence of interstitial lung disease or interstitial pneumonitis
• Bullous and exfoliative skin disorders at screening of any grade
• Presence of clinically significant ophthalmological abnormalities that might increase the risk of corneal epithelial injury