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

Stopped early · Phase 1

Conditions studied: Advanced EGFR Mutant Non Small Cell LungCancer (NSCLC), KRAS G12-mutant NSCLC, Esophageal Squamous Cell Cancer (SCC), Head/Neck SCC, Melanoma, Advanced Gastrointestinal Stromal Tumors (GIST), Advanced NRAS/BRAFT wt Cutaneous Melanoma

In brief

The purpose of this first in human (FIH) trial was 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.

Key facts

Study ID

NCT03114319

Run by

Novartis Pharmaceuticals

People needed

227

Starts

2017-05-26

Expected to finish

2025-07-04

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• H Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Dana Farber Cancer Center — Boston, Massachusetts, United States
• Memorial Sloane Ketterin Cancer Ctr — New York, New York, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Kobe, Japan
• Novartis Investigative Site — Rotterdam, South Holland, Netherlands
• Novartis Investigative Site — Amsterdam, Netherlands
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Seoul, South Korea
• Novartis Investigative Site — Seoul, South Korea
• Novartis Investigative Site — L'Hospitalet de Llobregat, Barcelona, Spain
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Taipei, Taiwan

Full record on ClinicalTrials.gov

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