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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03696771
Recruitment Status : Active, not recruiting
First Posted : October 5, 2018
Last Update Posted : September 22, 2020
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE September 4, 2018
First Posted Date  ICMJE October 5, 2018
Last Update Posted Date September 22, 2020
Actual Study Start Date  ICMJE December 27, 2018
Estimated Primary Completion Date October 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
  • Incidence and severity of dose limiting toxicities (DLTs) [ Time Frame: 21 days ]
    The time frame will expand to 42 days for the second part of the study
  • Number of participants with Adverse Events [ Time Frame: 2.5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
  • Concentration versus time profiles for NJH395 and its catabolite [ Time Frame: 126 days ]
  • PK parameter (Cmax) for NJH395 [ Time Frame: 126 days ]
  • Pharmacokinetic (PK) parameter (AUC) for NJH395 [ Time Frame: 126 days ]
  • Incidence of anti-NJH395 antibodies and neutralizing antibodies to trastuzumab [ Time Frame: 126 days ]
  • Overall Response Rate [ Time Frame: 2.5 years ]
    Response assessed by RECIST v1.1 and iRECIST
  • Clinical Benefit Rate (CBR) [ Time Frame: 2.5 years ]
    Response assessed by RECIST v1.1 and iRECIST
  • Progression Free Survival (PFS) [ Time Frame: 2.5 years ]
    Time from start of treatment to date of the first documented progression or death in months
  • Duration of Response (DOR) [ Time Frame: 2.5 years ]
    Response assessed by RECIST v1.1 and iRECIST
  • Characterization of tumor-infiltrating lymphocytes by IHC [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study to Determine Safety and Dose of NJH395 in Non-breast HER2+ Advanced Cancer
Official Title  ICMJE A Phase I, Multicenter, Open-label Dose Finding Study of NJH395, Administered Intravenously in Patients With Non-breast HER2+ Advanced Malignancies
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE NON-breast HER2+ Malignancies
Intervention  ICMJE Drug: NJH395
Immune stimulator antibody conjugate (ISAC), consisting of a monoclonal antibody which targets HER2 conjugated to an immune-stimulatory agent
Study Arms  ICMJE Experimental: NJH395
Includes non-breast HER2-positive advanced malignancies
Intervention: Drug: NJH395
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 19, 2020)
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2018)
Estimated Study Completion Date  ICMJE October 22, 2020
Estimated Primary Completion Date October 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Japan,   Korea, Republic of,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03696771
Other Study ID Numbers  ICMJE CNJH395X2101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP