ovartis sponsored Phase 1 study
- Conditions
- advanced solid tumor
- Registration Number
- JPRN-jRCT2080223249
- Lead Sponsor
- ovartis Pharma. K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 17
Phase I part: Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
- Phase II part: Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have had disease progression.
- ECOG Performance Status =< 1.
- History of severe hypersensitivity reactions to study treatment ingredients or other mAbs.
- Active, known or suspected autoimmune disease.
- Active infection requiring systemic antibiotic therapy.
- HIV infection, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Patients receiving chronic treatment with systemic steroid therapy other than replacement-dose steroids in the setting of adrenal insufficiency.
- Patients receiving systemic treatment with any immunosuppressive medication thought to interfere with the mechanism of action of the study drugs.
- Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment.
- Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment.
- Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids within the prior 2 weeks.
- History of drug-induced pneumonitis or current pneumonitis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method