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

  • STATUS
    Recruiting
  • End date
    Feb 27, 2024
  • participants needed
    255
  • sponsor
    Novartis Pharmaceuticals
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Updated on 13 April 2022
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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.

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.

Details
Condition Advanced EGFRmutant NonSmallSellLungCancer (NSCLC),KRAS G12-mutant NSCLC,Esophageal SquamousCellCancer (SCC),Head/Neck SCC,Melanoma
Treatment TNO155, TNO155 in combination with EGF816 (nazartinib)
Clinical Study IdentifierNCT03114319
SponsorNovartis Pharmaceuticals
Last Modified on13 April 2022

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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