NON-breast HER2+ Malignancies
Conditions
Interventions
investigational material(s)
Generic name etc : NJH395
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material
Sponsors
Novartis Pharma. K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient must have known histologically or cytologically confirmed and documented HER2-positive solid tumor excluding patients with breast cancer. Advanced/metastatic cancer who have progressed or are intolerant to all approved therapies known to confer clinical benefit. Eastern Cooperative Oncology Group (ECOG) performance status =<2. Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy prior to therapy, and during therapy on this study.
Exclusion criteria
Exclusion criteria: History of severe hypersensitivity to any ingredient of study drug, trastuzumab or other monoclonal antibody. Patients previously treated with TLR 7/8 agonist. Impaired cardiac function or history of clinically significant cardiac disease Active, known or suspected autoimmune disease. Human Immunodeficiency virus (HIV) infection History of or current interstitial lung disease or pneumonitis Grade 2 or greater. Discontinued prior checkpoint inhibitor due to a checkpoint inhibitor related toxicity. Currently receiving medications known to cause Torsades de Pointe that cannot be discontinued 7 days prior to starting treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Incidence and severity of dose limiting toxicities Number of participants with Adverse Events | — |
Countries
Asia except Japan, Europe, Japan, North America
Contacts
Public ContactMasataka Yonemura
Novartis Pharma. K.K.
Outcome results
None listed