臨床研究等提出・公開システム

An open-label, multi-center, phase I, dose finding study of oral TNO155 in adult patients with advanced solid tumors

Dose finding study of TNO155 in adult patients with advanced solid tumors

Yonemura Masataka

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

rinshoshiken.toroku2@novartis.com

Yonemura Masataka

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku2@novartis.com

completed

Sept. 14, 2018

Interventional

Unblinded, dose finding

treatment purpose

1

- 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.

- 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.

Both

solid tumor

TNO115 single agent or TNO115/nazartinib combination.

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.

Aug. 22, 2018