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

Trial number:
Trial phase:
Study type:
Targeted therapy, Biomarker
Overall status:

Study start date

May, 2017

Scientific title

An Open-label, Multi-center, Phase I, Dose Finding Study of Oral TNO155 in Adult Patients With Advanced Solid Tumors


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.

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

Study design

Primary purpose: Treatment, Allocation: Non-Randomized, Intervention model: Single Group Assignment, Masking: None (Open Label),


Advanced EGFRmutant NonSmallSellLungCancer (NSCLC),KRAS G12-mutant NSCLC,Esophageal SquamousCellCancer (SCC),Head/Neck SCC,Melanoma

Other study ID numbers

CTNO155X2101; 2016-001861-10

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