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

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

ClinicalTrials.gov Identifier: NCT03114319

Novartis Reference Number: CTNO155X2101

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

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.

Condition 
Advanced EGFRmutant NonSmallSellLungCancer (NSCLC),KRAS G12-mutant NSCLC,Esophageal SquamousCellCancer (SCC),Head/Neck SCC,Melanoma
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
255 participants
Start date 
May 26, 2017
Completion date 
Aug 02, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
TNO155
TNO155 for oral administration
Drug
TNO155 in combination with EGF816 (nazartinib)
TNO155 for oral administration; EGF816 (nazartinib) for oral administration

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 Locations

United States
Dana Farber Cancer Center
Recruiting
Boston, 02215
Massachusetts
United States
Memorial Sloan Kettering Cancer Center
Recruiting
New York, 10065
New York
United States
Sarah Cannon Research Institute
Recruiting
Nashville, 37221
Tennessee
United States
Canada
Novartis Investigative Site
Recruiting
Toronto, M5G 1Z5
Ontario
Canada
Japan
Novartis Investigative Site
Recruiting
Kobe-shi, 650-0017
Hyogo
Japan
Netherlands
Novartis Investigative Site
Recruiting
Amsterdam, 1066 CX
-
Netherlands
Novartis Investigative Site
Recruiting
Rotterdam, 3075 EA
-
Netherlands
Singapore
Novartis Investigative Site
Recruiting
Singapore, 169610
-
Singapore
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Hospitalet de LLobregat, 08907
Catalunya
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]