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

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.

Study Start Date

May, 26 2017

Estimated Completion Date

March 2020

Interventions

  • Drug: TNO155

Study ID

Novartis -- CTNO155X2101

Status

Recruiting

Trial ID

NCT03114319

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

105

Sponsor

Novartis

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 and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (3)

Study Location Distance Name Phone Email
Dana Farber Cancer Center - Boston, Massachusetts 2.4 miles Beth Meyers 617-643-1820 Betha_meyers@dfci.harvard.edu
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Murielle Georges 656-888-4563 georgesm@mskcc.org
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Murielle Georges 656-888-4563 georgesm@mskcc.org

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