A Phase I/II, open label, multicenter study of the safety and efficacy of LAG525 single agent and in combination with PDR001 administered to patients with advanced malignancies.

ovartis Pharma. K.K.0 个研究点目标入组 17 人开始时间: 2016年6月27日最近更新: 2023年10月17日

试验速览

暂无简介。

•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.

发起方

ovartis Pharma. K.K.