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

Phase 1

Completed

• Conditions: NON-breast HER2+ Malignancies
• Interventions: Drug: NJH395

• Registration Number: NCT03696771
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-05
• Study Start: 2018-12-27
• Primary Completion: 2020-10-19
• Study Completion: 2020-10-19
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-21
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NJH395	NJH395	Includes non-breast HER2-positive advanced malignancies

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events	2.5 years
Incidence and severity of dose limiting toxicities (DLTs)	21 days	The time frame will expand to 42 days for the second part of the study

Secondary Outcome Measures

Name	Time	Method
Concentration versus time profiles for NJH395 and its catabolite	126 days
Overall Response Rate	2.5 years	Response assessed by RECIST v1.1 and iRECIST
Pharmacokinetic (PK) parameter (AUC) for NJH395	126 days
Duration of Response (DOR)	2.5 years	Response assessed by RECIST v1.1 and iRECIST
PK parameter (Cmax) for NJH395	126 days
Incidence of anti-NJH395 antibodies and neutralizing antibodies to trastuzumab	126 days
Clinical Benefit Rate (CBR)	2.5 years	Response assessed by RECIST v1.1 and iRECIST
Progression Free Survival (PFS)	2.5 years	Time from start of treatment to date of the first documented progression or death in months
Characterization of tumor-infiltrating lymphocytes by IHC	Cycle 1 Day 5, Cycle 2 Day 1 (each cycle is 21 days), Cycle 8 Day 1 and at end of treatment (expected between months 6 and 7)	Change from baseline in TILs by immunohistochemistry (IHC) (such as CD8).

Trial Locations

Locations (2)

Novartis Investigative Site; 🇰🇷 Seoul, Korea, Republic of

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States