Description:
A first-in-human study using NJH395 in non-breast HER2-positive advanced malignancies
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
Drug | Synonyms | Arms |
---|
NJH395 | | NJH395 |
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
Name | Type | Description | Interventions |
---|
NJH395 | Experimental | Includes non-breast HER2-positive advanced malignancies | |
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: | Completed |
Lead Sponsor: | Novartis Pharmaceuticals |
Trial Keywords
- Phase I, NJH395, HER2+, ISAC, TLR7
Last Updated
June 4, 2021