Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors
About the study
Who can take part
INCLUSION CRITERIA
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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Study’s details
Contition
Advanced EGFRmutant NonSmallSellLungCancer (NSCLC),KRAS G12-mutant NSCLC,Esophageal SquamousCellCancer (SCC),Head/Neck SCC,Melanoma
Age (in years)
18 - 99
Phase
Phase 1
Participants needed
255
Est. Completion Date
Oct 29, 2024
Treatment type
Interventional
Sponsor
Novartis
ClinicalTrials.gov identifier
NCT03114319
Study number
CTNO155X2101
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?