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

NCT03114319 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2026-04-16

No results posted yet for this 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.

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

DRUG

TNO155

TNO155 for oral administration

DRUG

TNO155 in combination with EGF816 (nazartinib)

TNO155 for oral administration; EGF816 (nazartinib) for oral administration

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-26
Primary Completion
2025-07-04
Completion
2025-07-04
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Italy
  • Japan
  • Netherlands
  • Singapore
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03114319 on ClinicalTrials.gov