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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 )

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

Condition or disease Intervention/treatment Phase
NON-breast HER2+ Malignancies Drug: NJH395 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Multicenter, Open-label Dose Finding Study of NJH395, Administered Intravenously in Patients With Non-breast HER2+ Advanced Malignancies
Actual Study Start Date : December 27, 2018
Estimated Primary Completion Date : October 21, 2020
Estimated Study Completion Date : October 22, 2020

Arm Intervention/treatment
Experimental: NJH395
Includes non-breast HER2-positive advanced malignancies
Drug: NJH395
Immune stimulator antibody conjugate (ISAC), consisting of a monoclonal antibody which targets HER2 conjugated to an immune-stimulatory agent

Primary Outcome Measures :
  1. 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

  2. Number of participants with Adverse Events [ Time Frame: 2.5 years ]

Secondary Outcome Measures :
  1. Concentration versus time profiles for NJH395 and its catabolite [ Time Frame: 126 days ]
  2. PK parameter (Cmax) for NJH395 [ Time Frame: 126 days ]
  3. Pharmacokinetic (PK) parameter (AUC) for NJH395 [ Time Frame: 126 days ]
  4. Incidence of anti-NJH395 antibodies and neutralizing antibodies to trastuzumab [ Time Frame: 126 days ]
  5. Overall Response Rate [ Time Frame: 2.5 years ]
    Response assessed by RECIST v1.1 and iRECIST

  6. Clinical Benefit Rate (CBR) [ Time Frame: 2.5 years ]
    Response assessed by RECIST v1.1 and iRECIST

  7. 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

  8. Duration of Response (DOR) [ Time Frame: 2.5 years ]
    Response assessed by RECIST v1.1 and iRECIST

  9. 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03696771

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Novartis Investigative Site
Milano, MI, Italy, 20162
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277 8577
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT03696771    
Other Study ID Numbers: CNJH395X2101
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Phase I, NJH395, HER2+, ISAC, TLR7
Additional relevant MeSH terms:
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