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

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Disease Information

Descriptive Information
Brief Title † Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors
Official Title † An Open-label, Multi-center, Phase I, Dose Finding Study of Oral TNO155 in Adult Patients With Advanced Solid Tumors
Brief Summary 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.
Detailed Description This study has been designed as a Phase I, open-label, dose finding study with a dose escalation part and a dose expansion part in adult patients with selected advanced solid tumors. The study treatment, TNO155, will be taken until the patient experiences unacceptable toxicity, progressive disease and/or treatment is discontinued at the discretion of the investigator or the patient or due to withdrawal of consent. Some patients will be participating in a food effect investigation as an exploratory objective.
Study Phase Phase 1
Study Type † Interventional
Study Design †
Primary Outcome Measure † Number of participants with adverse events
Secondary Outcome Measure † Area under the curve
Condition † Patients With Advanced EGFR-mutant Non-smallcell Lung Cancer Head-and-Neck Squamous Cell Cancer, RAS/RAF Wild-type Other Solid Tumors
Intervention † DrugTNO155
Study Arms / Comparison Groups TNO155 TNO155 for oral administration
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 105
Start Date † May 31, 2017
Completion Date March 18, 2020
Primary Completion Date March 18, 2020
Eligibility Criteria † Inclusion Criteria: 1. Able to understand and voluntarily sign the ICF and able to comply with the study visit schedule and the other protocol requirements. 2. Patient (male or female) ≥18 years of age willing to agree to not father a child/become pregnant and comply with effective contraception criteria. 3. 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. 4. ECOG (Eastern cooperative oncology group) performance status ≤2 Exclusion Criteria: 1. Tumors harboring known activating KRAS, NRAS, HRAS, BRAF or PTPN11 (SHP2) mutations. 2. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO. 3. 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. 4. Clinically significant cardiac disease. 5. Active diarrhea or inflammatory bowel disease 6. Insufficient bone marrow function 7. Insufficient hepatic and renal function.
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Novartis Pharmaceuticals, 1-888-669-6682, trialandresults.registries@novartis.com
Location Countries †
Administrative Information
NCT ID † NCT03114319
Organization ID CTNO155X2101
Secondary IDs †† 2016-001861-10
Responsible Party Sponsor
Study Sponsor † Novartis Pharmaceuticals
Collaborators ††
Investigators † Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Information Provided By
Verification Date May 2017
First Received Date † April 11, 2017
Last Updated Date May 1, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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