Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03114319 · ClinicalTrials.gov registry record · Phase 1
Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 227
- Enrollment target
NCT03114319: Clinical Trial Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT03114319 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 227 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (278% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03114319, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 227 participants
- Enrollment target
Study 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.
Primary Outcome
All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms and cardiac biomarkers
Interventions
- DRUG TNO155
- DRUG TNO155 in combination with EGF816 (nazartinib)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 227 participants |
| Start Date | 2017-05-26 |
| Est. Completion | 2025-07-04 |
| Phase | Phase 1 |
Why NCT03114319 stopped before completion
NCT03114319 is an interventional study that assigns participants to a tested intervention. The registered 227 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (278% higher).
The record links to 0 conditions, and to 2 interventions - of which TNO155 is the first listed.
NCT03114319 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03114319 about?
NCT03114319 is a clinical study titled "Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors". 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.
What is the current status of trial NCT03114319?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 227 participants. The study started on 2017-05-26. Estimated completion is 2025-07-04.
What interventions are being tested in trial NCT03114319?
The interventions under investigation include: TNO155 (DRUG), TNO155 in combination with EGF816 (nazartinib) (DRUG).
Who is sponsoring clinical trial NCT03114319?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03114319's enrollment target sits among peer trials
227 221st of 2000 higher than 1,780 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04751409 · 227 participants · Phase 2
Evaluating the Impact of Limited Compared With Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Stage II-III Soft Tissue Sarcoma of the Trunk and Extremities
- NCT05742360 · 227 participants
Effect of CPAP on Blood Pressure in Excessively Sleepy Obstructive Sleep Apnea Subtype
- NCT05890352 · 227 participants · Phase 2
Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment
- NCT05107908 · 228 participants · NA
Neuronal and Behavioral Effects of an Implicit Priming Approach to Improve Eating Behaviors in Obesity
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI