Protocol #: 17-251
Status
Recruiting
Description
The purpose of this first in human (FIH) trial is to characterize the safety and tolerability of the SHP2 inhibitor TNO155 and identify a recommended dose for future studies in adult patients with advanced solid tumors in selected indications.
Condition
Advanced EGFRmutant NonSmallSellLungCancer (NSCLC),KRAS G12C NSCLC,CRC,Esophageal SquamousCellCancer (SCC),Head/Neck SCC,RAS/RAF Wild-type Other Solid Tumor
Interventions
TNO155
Phase
Phase 1
Study Type
Interventional
Further Study Details
Primary Outcome:
Number of participants with adverse events
Number of participants with dose limiting toxicities
Secondary Outcome:
Area under the curve
Overall response rate
pERK
Cmax
tmax
apparent terminal elimination half-life
Estimated Enrollment
135
Study Start Date
May 26, 2017
Eligibility
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Health Volunteers: No
Criteria
Novartis Pharmaceuticals
Information Provided By
Novartis
Official Title
An Open-label, Multi-center, Phase I, Dose Finding Study of Oral TNO155 in Adult Patients With Advanced Solid Tumors
Clinicaltrials.gov Identifier
NCT03114319

 

 

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.

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