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

Last updated: February 26, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

1

Condition

Melanoma

Treatment

TNO155 in combination with EGF816 (nazartinib)

TNO155

Clinical Study ID

NCT03114319
CTNO155X2101
2016-001861-10
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able to understand and voluntarily sign the ICF and able to comply with the studyvisit schedule and the other protocol requirements.

  2. Patient (male or female) ≥18 years of age willing to agree to not father achild/become pregnant and comply with effective contraception criteria.

  3. Must have progressed following standard therapy, or for whom, in the opinion of theInvestigator, no effective standard therapy exists, is tolerated or is appropriate.

  4. ECOG (Eastern cooperative oncology group) performance status ≤2 Additional criteria only appying to TNO155 in combination with EGF816 (nazartinib):

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

Exclusion

Exclusion Criteria:

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

  2. History or current evidence of retinal vein occlusion (RVO) or current risk factorsfor RVO.

  3. Any medical condition that would, in the investigator's judgment, prevent thepatient's participation in the clinical study due to safety concerns or compliancewith 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. Additional criteria only appying to TNO155 in combination with EGF816 (nazartinib):

  8. Patients with a known history of human immunodeficiency virus (HIV) seropositivity.

  9. Patients receiving concomitant immunosuppressive agents or chronic corticosteroidsuse at the time of study entry.

  10. Patients who have undergone a bone marrow or solid organ transplant

  11. Patients with a history or presence of interstitial lung disease or interstitialpneumonitis

  12. Bullous and exfoliative skin disorders at screening of any grade

  13. Presence of clinically significant ophthalmological abnormalities that mightincrease the risk of corneal epithelial injury

Study Design

Total Participants: 227
Treatment Group(s): 2
Primary Treatment: TNO155 in combination with EGF816 (nazartinib)
Phase: 1
Study Start date:
May 26, 2017
Estimated Completion Date:
November 07, 2025

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Novartis Investigative Site

    Milano, MI 20141
    Italy

    Site Not Available

  • Novartis Investigational Site

    Kobe,
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kobe shi, 650-0017
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kobe-shi, 650-0017
    Japan

    Site Not Available

  • Novartis Investigative Site

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Rotterdam, Zuid Holland 3015 GD
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Leiden, 2300 RC
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Singapore, 168583
    Singapore

    Site Not Available

  • Novartis Investigative Site

    Barcelona, Catalunya 08035
    Spain

    Site Not Available

  • Novartis Investigative Site

    Hospitalet de LLobregat, Catalunya 08907
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28040
    Spain

    Site Not Available

  • Novartis Investigative Site

    Taipei, 10002
    Taiwan

    Site Not Available

  • H Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida 33612
    United States

    Site Not Available

  • H Lee Moffitt Cancer Center and Research Institute .

    Tampa, Florida 33612
    United States

    Site Not Available

  • Dana Farber Cancer Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Novartis Investigative Site

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloane Ketterin Cancer Ctr

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloane Ketterin Cancer Ctr Main Centre

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloane Kettering Cancer Center Main Centre

    New York, New York 10065
    United States

    Active - Recruiting

  • NYU Langone Health .

    New York, New York 10016
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37221
    United States

    Site Not Available

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