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

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224175

Enrollment

Registered

2018-12-06

Start date

2018-09-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

solid tumor

Interventions

TNO115 single agent or TNO115/nazartinib combination.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Able to understand and voluntarily sign the ICF and ability to comply with the study visit schedule and the other protocol requirements. - Must have progressed on or been intolerant to standard therapy. - ECOG (Eastern cooperative oncology group) performance status =<2 - Patients must be screened for HBV.

Exclusion criteria

Exclusion criteria: - Tumors harboring known activating KRAS, NRAS, HRAS, BRAF or PTPN11 mutations, with the exception of KRAS G12-mutant NSCLC. - History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO. - Any medical condition that would, in the investigator judgment, prevent the patient participation in the clinical study due to safety concerns or compliance with clinical study procedures. - Clinically significant cardiac disease. - Active diarrhea or inflammatory bowel disease. - Insufficient bone marrow function. - Insufficient hepatic and renal function. Additional exclusion criteria for TNO155 in combination with nazartinib: - Patients with a known history of human immunodeficiency virus (HIV) seropositivity. - Patients receiving concomitant immunosuppressive agents or with chronic corticosteroids use at the time of study entry. - Patients who have undergone a bone marrow or solid organ transplant. - Patients with history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis. - Presence of clinically significant ophthalmologic abnormalities. - Bullous and exfoliative skin disorders at screening of any grade.

Design outcomes

Primary

Measure	Time frame
Safety. To characterize safety and tolerability of TNO155 as a single agent and in combination with nazartinib, and identify recommended regimens for future studies in adult patients with advanced solid tumors.	—

Countries

Asia except Japan, Europe, Japan, North America

Contacts

Public ContactSanae Moizumi

Novartis Pharma. K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026