Esophageal Cancer Clinical Trial

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

Summary

The purpose of this first in human (FIH) trial is to characterize the safety and tolerability of the SHP2 inhibitor TNO155 alone and in combination with EGF816 (nazartinib) and identify a recommended dose for future studies in adult patients with advanced solid tumors in selected indications.

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Full 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 alone or in combination with EGF816 (nazartinib), 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.

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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

Additional criteria only appying to TNO155 in combination with EGF816 (nazartinib):

Patients must be screened for Hepatitis B virus and Hepatitis C virus

Exclusion Criteria:

Tumors harboring known activating KRAS, NRAS, HRAS, BRAF or PTPN11 (SHP2) mutations. (Exceptions are KRAS G12-mutant NSCLC's)
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.

Additional criteria only appying to TNO155 in combination with EGF816 (nazartinib):

Patients with a known history of human immunodeficiency virus (HIV) seropositivity.
Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use at the time of study entry.
Patients who have undergone a bone marrow or solid organ transplant
Patients with a history or presence of interstitial lung disease or interstitial pneumonitis
Bullous and exfoliative skin disorders at screening of any grade
Presence of clinically significant ophthalmological abnormalities that might increase the risk of corneal epithelial injury

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

255

Study ID:

NCT03114319

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 15 Locations for this study

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Dana Farber Cancer Center
Boston Massachusetts, 02215, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Hawa Camara
Contact
656-888-4563
[email protected]
Helena Yu
Principal Investigator
Sarah Cannon Research Institute
Nashville Tennessee, 37221, United States
Novartis Investigative Site
Toronto Ontario, M5G 1, Canada
Novartis Investigative Site
Kobe-shi Hyogo, 650-0, Japan
Novartis Investigative Site
Seoul , 03080, Korea, Republic of
Novartis Investigative Site
Seoul , 05505, Korea, Republic of
Novartis Investigative Site
Amsterdam , 1066 , Netherlands
Novartis Investigative Site
Rotterdam , 3075 , Netherlands
Novartis Investigative Site
Singapore , 16961, Singapore
Novartis Investigative Site
Barcelona Catalunya, 08035, Spain
Novartis Investigative Site
Hospitalet de LLobregat Catalunya, 08907, Spain
Novartis Investigative Site
Madrid , 28009, Spain
Novartis Investigative Site
Madrid , 28034, Spain
Novartis Investigative Site
Taipei , 10002, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

255

Study ID:

NCT03114319

Recruitment Status:

Recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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