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

Status: Active

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.

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

Exclusion Criteria

  • Tumors harboring known activating KRAS, NRAS, HRAS, BRAF or PTPN11 (SHP2) mutations. (Exceptions are KRAS G12C CRC and KRAS G12C NSCLC)
  • 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.

Locations & Contacts

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Active
Contact: Beth A. Meyers
Phone: 617-643-1820
Email: Betha_meyers@dfci.harvard.edu

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Novartis Pharmaceuticals Corporation

Trial IDs

Primary ID CTNO155X2101
Secondary IDs NCI-2017-01726, 2016-001861-10
Clinicaltrials.gov ID NCT03114319