Clinical Trial Finder

Inclusion Criteria:

1. Able to understand and voluntarily sign the ICF and able to comply with the study visit schedule and the other protocol requirements. 2. Patient (male or female) ≥18 years of age willing to agree to not father a child/become pregnant and comply with effective contraception criteria. 3. 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. 4. ECOG (Eastern cooperative oncology group) performance status ≤2. Additional criteria only appying to TNO155 in combination with EGF816 (nazartinib): 5. Patients must be screened for Hepatitis B virus and Hepatitis C virus.

Exclusion Criteria:

1. Tumors harboring known activating KRAS, NRAS, HRAS, BRAF or PTPN11 (SHP2) mutations. (Exceptions are KRAS G12-mutant NSCLC's) 2. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO. 3. 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. 4. Clinically significant cardiac disease. 5. Active diarrhea or inflammatory bowel disease. 6. Insufficient bone marrow function. 7. Insufficient hepatic and renal function. Additional criteria only appying to TNO155 in combination with EGF816 (nazartinib): 8. Patients with a known history of human immunodeficiency virus (HIV) seropositivity. 9. Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use at the time of study entry. 10. Patients who have undergone a bone marrow or solid organ transplant. 11. Patients with a history or presence of interstitial lung disease or interstitial pneumonitis. 12. Bullous and exfoliative skin disorders at screening of any grade. 13. Presence of clinically significant ophthalmological abnormalities that might increase the risk of corneal epithelial injury

This study has been designed as a Phase I, open-label, dose finding study with a dose escalation part and a dose expansion part in adult patients with selected advanced solid tumors. The study treatment, TNO155 alone or in combination with EGF816 (nazartinib), will be taken until the patient experiences unacceptable toxicity, progressive disease and/or treatment is discontinued at the discretion of the investigator or the patient or due to withdrawal of consent.

Arms

Experimental: TNO155

TNO155 for oral administration

Experimental: TNO155 in combination with EGF816 (nazartinib)

TNO155 in combination with EGF816 (nazartinib) in patients with advanced EGFR mutant NSCLC

Interventions

Drug: - TNO155

TNO155 for oral administration

Drug: - TNO155 in combination with EGF816 (nazartinib)

TNO155 for oral administration; EGF816 (nazartinib) for oral administration