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

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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)

18 participants in 1 patient group

NJH395
Experimental group
Description:
Includes non-breast HER2-positive advanced malignancies
Treatment:
Drug: NJH395

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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