Study Description
The purpose of this first in human (FIH) trial is to characterize the safety and tolerability of the SHP2 inhibitor TNO155 alone and in combination with EGF816 (nazartinib) and identify a recommended dose for future studies in adult patients with advanced solid tumors in selected indications.
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. Some patients will be participating in a food effect investigation as an exploratory objective.
Interventions
TNO155
TNO155 in combination with EGF816 (nazartinib)
Eligibility 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:
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 Location
Novartis Investigative Site
Recruiting
Toronto,Ontario,M5G 1Z5,Canada
Novartis Investigative Site
Recruiting
Milano,MI,20141,Italy
Novartis Investigative Site
Recruiting
Kobe-shi,Hyogo,650-0017,Japan
Novartis Investigative Site
Recruiting
Seoul,03080,Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul,05505,Korea, Republic of
Novartis Investigative Site
Recruiting
Leiden,2300 RC,Netherlands
Novartis Investigative Site
Recruiting
Amsterdam,1066 CX,Netherlands
Novartis Investigative Site
Recruiting
Rotterdam,3075 EA,Netherlands
Novartis Investigative Site
Recruiting
Singapore,168583,Singapore
Novartis Investigative Site
Recruiting
Madrid,28009,Spain
Novartis Investigative Site
Recruiting
Madrid,28034,Spain
Novartis Investigative Site
Recruiting
Madrid,28040,Spain
Novartis Investigative Site
Recruiting
Barcelona,Catalunya,08035,Spain
Novartis Investigative Site
Recruiting
Hospitalet de LLobregat,Catalunya,08907,Spain
Novartis Investigative Site
Recruiting
Taipei,10002,Taiwan
H Lee Moffitt Cancer Center and Research Institute .
Recruiting
Tampa,Lina Gant (888-663-3488) email: [email protected] -- Ahmad Tarhini,33612 - Florida,United States
NYU Langone Health .
Recruiting
New York,Sofia Bajwa email: [email protected] -- Janice Mehnert,10016 - New York,United States
Worldwide Contacts
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