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

ovartis Pharma. K.K.0 个研究点目标入组 15 人开始时间: 2018年12月6日最近更新: 2023年10月17日

适应症

试验速览

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•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.

发起方

ovartis Pharma. K.K.