Clinical Trials /

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

NCT03696771

Description:

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

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study to Determine Safety and Dose of NJH395 in Non-breast HER2+ Advanced Cancer
  • Official Title: A Phase I, Multicenter, Open-label Dose Finding Study of NJH395, Administered Intravenously in Patients With Non-breast HER2+ Advanced Malignancies

Clinical Trial IDs

  • ORG STUDY ID: CNJH395X2101
  • NCT ID: NCT03696771

Conditions

  • NON-breast HER2+ Malignancies

Interventions

DrugSynonymsArms
NJH395NJH395

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
NJH395ExperimentalIncludes non-breast HER2-positive advanced malignancies
  • NJH395

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence and severity of dose limiting toxicities (DLTs)
Time Frame:21 days
Safety Issue:
Description:The time frame will expand to 42 days for the second part of the study

Secondary Outcome Measures

Measure:Concentration versus time profiles for NJH395 and its catabolite
Time Frame:126 days
Safety Issue:
Description:
Measure:PK parameter (Cmax) for NJH395
Time Frame:126 days
Safety Issue:
Description:
Measure:Pharmacokinetic (PK) parameter (AUC) for NJH395
Time Frame:126 days
Safety Issue:
Description:
Measure:Incidence of anti-NJH395 antibodies and neutralizing antibodies to trastuzumab
Time Frame:126 days
Safety Issue:
Description:
Measure:Overall Response Rate
Time Frame:2.5 years
Safety Issue:
Description:Response assessed by RECIST v1.1 and iRECIST
Measure:Clinical Benefit Rate (CBR)
Time Frame:2.5 years
Safety Issue:
Description:Response assessed by RECIST v1.1 and iRECIST
Measure:Progression Free Survival (PFS)
Time Frame:2.5 years
Safety Issue:
Description:Time from start of treatment to date of the first documented progression or death in months
Measure:Duration of Response (DOR)
Time Frame:2.5 years
Safety Issue:
Description:Response assessed by RECIST v1.1 and iRECIST
Measure: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)
Safety Issue:
Description:Change from baseline in TILs by immunohistochemistry (IHC) (such as CD8).

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • Phase I, NJH395, HER2+, ISAC, TLR7

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