deltatrials
Terminated INTERVENTIONAL NCT03114319

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

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

Sponsor: Novartis Pharmaceuticals

Conditions Advanced EGFR Mutant Non Small Cell LungCancer (NSCLC) Advanced Gastrointestinal Stromal Tumors (GIST) Advanced NRAS/BRAFT wt Cutaneous Melanoma Esophageal Squamous Cell Cancer (SCC) Head/Neck SCC KRAS G12-mutant NSCLC Melanoma
Interventions TNO155 TNO155 in combination with EGF816 (nazartinib)
Updated 42 times since 2017 Last updated: Apr 13, 2026 Started: May 26, 2017 Primary completion: Jul 4, 2025 Completion: Jul 4, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Business reasons and not due to any safety concerns

Other terminated trials from Novartis Pharmaceuticals

See all terminations from Novartis Pharmaceuticals

A observational or N/A phase clinical study on Advanced EGFR Mutant Non Small Cell LungCancer (NSCLC) and Advanced Gastrointestinal Stromal Tumors (GIST), this trial is terminated or withdrawn. The trial is conducted by Novartis Pharmaceuticals and has accumulated 42 data snapshots since 2017. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

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), was taken until the patient experienced unacceptable toxicity, progressive disease and/or treatment was discontinued at the discretion of the investigator or the patient or due to withdrawal of consent.

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), was taken until the patient experienced unacceptable toxicity, progressive disease and/or treatment was discontinued at the discretion of the investigator or the patient or due to withdrawal of consent.

Status Flow

~May 2017 – ~Jun 2017 · 31 days · monthly snapshot~Jun 2017 – ~Aug 2017 · 2 months · monthly snapshot~Aug 2017 – ~Oct 2017 · 2 months · monthly snapshot~Oct 2017 – ~Jun 2018 · 8 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Nov 2018 · 4 months · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Feb 2019 · 2 months · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Jul 2019 · 4 months · monthly snapshot~Jul 2019 – ~Mar 2020 · 8 months · monthly snapshot~Mar 2020 – ~Jun 2020 · 3 months · monthly snapshot~Jun 2020 – ~Jan 2021 · 7 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~May 2021 · 2 months · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Jan 2022 · 4 months · monthly snapshot~Jan 2022 – ~Apr 2022 · 3 months · monthly snapshot~Apr 2022 – ~Sep 2022 · 5 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Apr 2023 · 5 months · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Nov 2023 · 3 months · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Feb 2024 · 2 months · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~May 2024 · 2 months · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Mar 2025 · 5 months · monthly snapshot~Mar 2025 – ~Jun 2025 · 3 months · monthly snapshot~Jun 2025 – ~Aug 2025 · 2 months · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Apr 2026 · 7 months · monthly snapshotApr 17, 2026 – present · 3 months · daily API

Change History

42 versions recorded

  1. Apr 17, 2026 — Present [daily]

    Terminated

    Phase: PHASE1 → None

  2. Sep 2025 — Apr 2026 [monthly]

    Terminated PHASE1

    Status: Active Not Recruiting → Terminated

  3. Aug 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE1

  4. Jun 2025 — Aug 2025 [monthly]

    Active Not Recruiting PHASE1

  5. Mar 2025 — Jun 2025 [monthly]

    Active Not Recruiting PHASE1

▶ Show 37 earlier versions

  1. Oct 2024 — Mar 2025 [monthly]

    Active Not Recruiting PHASE1

  2. Sep 2024 — Oct 2024 [monthly]

    Active Not Recruiting PHASE1

  3. Aug 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1

  4. Jul 2024 — Aug 2024 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  5. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE1

  6. May 2024 — Jun 2024 [monthly]

    Recruiting PHASE1

  7. Mar 2024 — May 2024 [monthly]

    Recruiting PHASE1

  8. Feb 2024 — Mar 2024 [monthly]

    Recruiting PHASE1

  9. Dec 2023 — Feb 2024 [monthly]

    Recruiting PHASE1

  10. Nov 2023 — Dec 2023 [monthly]

    Recruiting PHASE1

  11. Aug 2023 — Nov 2023 [monthly]

    Recruiting PHASE1

  12. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE1

  13. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE1

  14. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE1

  15. Apr 2023 — May 2023 [monthly]

    Recruiting PHASE1

  16. Nov 2022 — Apr 2023 [monthly]

    Recruiting PHASE1

  17. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE1

  18. Apr 2022 — Sep 2022 [monthly]

    Recruiting PHASE1

  19. Jan 2022 — Apr 2022 [monthly]

    Recruiting PHASE1

  20. Sep 2021 — Jan 2022 [monthly]

    Recruiting PHASE1

  21. May 2021 — Sep 2021 [monthly]

    Recruiting PHASE1

  22. Mar 2021 — May 2021 [monthly]

    Recruiting PHASE1

  23. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE1

  24. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE1

  25. Jun 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

  26. Mar 2020 — Jun 2020 [monthly]

    Recruiting PHASE1

  27. Jul 2019 — Mar 2020 [monthly]

    Recruiting PHASE1

  28. Mar 2019 — Jul 2019 [monthly]

    Recruiting PHASE1

  29. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE1

  30. Dec 2018 — Feb 2019 [monthly]

    Recruiting PHASE1

  31. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE1

  32. Jul 2018 — Nov 2018 [monthly]

    Recruiting PHASE1

  33. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE1

  34. Oct 2017 — Jun 2018 [monthly]

    Recruiting PHASE1

  35. Aug 2017 — Oct 2017 [monthly]

    Recruiting PHASE1

    Status: Not Yet Recruiting → Recruiting

  36. Jun 2017 — Aug 2017 [monthly]

    Not Yet Recruiting PHASE1

  37. May 2017 — Jun 2017 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

The purpose of this first in human (FIH) trial was 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.

Contact Information

Sponsor contact:
  • Novartis Pharmaceuticals
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Amsterdam, Netherlands , Barcelona, Spain , Boston, United States , Kobe, Japan , L'Hospitalet de Llobregat, Spain , Madrid, Spain , Madrid, Spain , Madrid, Spain , Milan, Italy , Nashville, United States and 8 more locations