Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors
- Trial number:
- NCT03114319
- Trial phase:
- 1
- Study type:
- Targeted therapy, Biomarker
- Overall status:
- Recruiting
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
Summary
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),
Conditions
Advanced EGFRmutant NonSmallSellLungCancer (NSCLC),KRAS G12-mutant NSCLC,Esophageal SquamousCellCancer (SCC),Head/Neck SCC,Melanoma
Other study ID numbers
CTNO155X2101; 2016-001861-10
Choose trial site (23)
Dana Farber Cancer Center
450 Brookline Ave, Boston, MA 02215, USA
Memorial Sloan Kettering Cancer Center
1275 York Ave, New York, NY 10065, USA
Sarah Cannon Research Institute
250 25th Ave N, Nashville, TN 37203, USA
Novartis Investigative Site
Toronto, ON M5G 1Z5, Canada
Novartis Investigative Site
650-0017, Japan
Novartis Investigative Site
89, Hullenbergweg 81, 1101 CL Amsterdam, Netherlands
Novartis Investigative Site
3075 EA Rotterdam, Netherlands
National Cancer Centre Singapore
20 Pasir Panjang Rd, #10-25/28 Mapletree Business City, Singapore 117439
Novartis Investigative Site
Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Novartis Investigative Site
08907 L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
Taipei City, Taiwan
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
28034 Madrid, Spain
Novartis Investigative Site
28009 Madrid, Spain
Novartis Investigative Site
28040 Madrid, Spain
H Lee Moffitt Cancer Center and Research Institute
12902 USF Magnolia Drive, Tampa, FL 33612, USA
Novartis Investigative Site
20141 Milan, Metropolitan City of Milan, Italy
Novartis Investigative Site
Leiden, Netherlands
Novartis Investigative Site
Singapore
NYU Langone Health .
New York, NY 10016, USA
H Lee Moffitt Cancer Center and Research Institute .
12902 USF Magnolia Drive, Tampa, FL 33612, USA
Memorial Sloane Kettering Cancer Center Main Centre
New York, NY 10065, USA