Study to Determine Safety and Dose of NJH395 in Non-breast HER2+ Advanced Cancer

• Status: Completed
• Trial end date: 2020-10-19
• Target enrollment: 0
• Participant gender: All

Summary

A first-in-human study using NJH395 in non-breast HER2-positive advanced malignancies

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Key Inclusion Criteria:

• Patient must have known histologically or cytologically confirmed and documented HER2-positive solid tumor excluding patients with breast cancer

• Advanced/metastatic cancer with measurable disease as determined by RECIST v.1.1 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.

Key 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

Other protocol defined inclusion/exclusion criteria may apply.