advanced solid tumor
Conditions
Interventions
Arm A: single-agent LAG525 cohort
Arm B: Combination LAG525 + PDR001 cohort
Arm C: Single-agent LAG525 in Japanese patients
Sponsors
Novartis Pharma. K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy To estimate the RP2D or MTD for single agent LAG525 in all patients (including for Japanese patients). To estimate the RP2D or MTD for the combination of LAG525 and PDR001. To estimate the overall response rate for single agent LAG525 as well as for the combination of LAG525 and PDR001. | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania
Contacts
Public ContactTakamitsu Hirano
Novartis Pharma. K.K.
Outcome results
None listed