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

Novartis

Status and phase: Completed; Phase 1

Conditions: NON-breast HER2+ Malignancies

Treatments: Drug: NJH395

Study type: Interventional

Funder types: Industry

Identifiers

NCT03696771

CNJH395X2101

Details and patient eligibility

About

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

Full description

This study has two parts. There will be a single dose of NJH395 in the first part and multiple doses of NJH395 in the second part. After the first part is completed, the second part may open.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

NJH395

Experimental group

Description:

Includes non-breast HER2-positive advanced malignancies

Treatment:

Drug: NJH395