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



Status:Recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/20/2019
Start Date:May 26, 2017
End Date:August 3, 2020
Contact:Novartis Pharmaceuticals
Email:trialandresults.registries@novartis.com
Phone:1-888-669-6682

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

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.

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.

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.
(Exceptions are KRAS G12C CRC and KRAS G12C NSCLC)

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.
We found this trial at
4
sites
230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Principal Investigator: Helena Yu
Phone: 656-888-4563
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Boston, Massachusetts 02118
Principal Investigator: Geoffrey Shapiro
Phone: 617-643-1820
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Nashville, Tennessee 37205
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Toronto, Ontario
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