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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-27

Study Completion Date

2020-10-19

Brief Summary

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

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Detailed Description

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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.

Conditions

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NON-breast HER2+ Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NJH395

Includes non-breast HER2-positive advanced malignancies

Group Type EXPERIMENTAL

NJH395

Intervention Type DRUG

Immune stimulator antibody conjugate (ISAC), consisting of a monoclonal antibody which targets HER2 conjugated to an immune-stimulatory agent

Interventions

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NJH395

Immune stimulator antibody conjugate (ISAC), consisting of a monoclonal antibody which targets HER2 conjugated to an immune-stimulatory agent

Intervention Type DRUG

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No