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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed 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), 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.

Conditions

• Advanced EGFR Mutant Non Small Cell LungCancer (NSCLC)
• KRAS G12-mutant NSCLC
• Esophageal Squamous Cell Cancer (SCC)
• Head/Neck SCC
• Melanoma
• Advanced Gastrointestinal Stromal Tumors (GIST)
• Advanced NRAS/BRAFT wt Cutaneous Melanoma

Interventions

Type	Name	Description
DRUG	TNO155	TNO155 for oral administration
DRUG	TNO155 in combination with EGF816 (nazartinib)	TNO155 for oral administration; EGF816 (nazartinib) for oral administration

Timeline

• Start date: 2017-05-26
• Primary completion: 2025-07-04
• Completion: 2025-07-04
• First posted: 2017-04-14
• Last updated: 2026-04-16

Locations

18 sites across 9 countries: United States, Canada, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study