Dose finding study of TNO155 in adult patients with advanced solid tumors
- Conditions
- solid tumor
- Registration Number
- JPRN-jRCT2080224175
- Lead Sponsor
- ovartis Pharma. K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- 15
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety.<br>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.
- Secondary Outcome Measures
Name Time Method