Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors
Advanced EGFRmutant NonSmallSellLungCancer (NSCLC),KRAS G12-mutant NSCLC,Esophageal SquamousCellCancer (SCC),Head/Neck SCC,Melanoma
About this trial
This is an interventional treatment trial for Advanced EGFRmutant NonSmallSellLungCancer (NSCLC),KRAS G12-mutant NSCLC,Esophageal SquamousCellCancer (SCC),Head/Neck SCC,Melanoma focused on measuring TNO155, SHP2, advanced solid tumor, NSCLC, HNSCC, Esophageal SCC, Melanoma, EGFR, KRAS G12C, GIST, PTPN11, cancers with a mass, bulky tumor, nodule, lump, advanced solid malignancies
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
Sites / Locations
- H Lee Moffitt Cancer Center and Research Institute .Recruiting
- Dana Farber Cancer Center
- NYU Langone Health .Recruiting
- Memorial Sloane Kettering Cancer Center Main CentreRecruiting
- Sarah Cannon Research Institute
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
TNO155
TNO155 in combination with EGF816 (nazartinib)
TNO155 for oral administration
TNO155 in combination with EGF816 (nazartinib) in patients with advanced EGFR mutant NSCLC