NON-breast HER2+ Malignancies Clinical Trial
Official title:
A Phase I, Multicenter, Open-label Dose Finding Study of NJH395, Administered Intravenously in Patients With Non-breast HER2+ Advanced Malignancies
| Verified date | January 2022 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A first-in-human study using NJH395 in non-breast HER2-positive advanced malignancies
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | October 19, 2020 |
| Est. primary completion date | October 19, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Novartis Investigative Site | Milano | MI |
| Japan | Novartis Investigative Site | Kashiwa | Chiba |
| Korea, Republic of | Novartis Investigative Site | Seoul | |
| United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Italy, Japan, Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence and severity of dose limiting toxicities (DLTs) | The time frame will expand to 42 days for the second part of the study | 21 days | |
| Primary | Number of participants with Adverse Events | 2.5 years | ||
| Secondary | Concentration versus time profiles for NJH395 and its catabolite | 126 days | ||
| Secondary | PK parameter (Cmax) for NJH395 | 126 days | ||
| Secondary | Pharmacokinetic (PK) parameter (AUC) for NJH395 | 126 days | ||
| Secondary | Incidence of anti-NJH395 antibodies and neutralizing antibodies to trastuzumab | 126 days | ||
| Secondary | Overall Response Rate | Response assessed by RECIST v1.1 and iRECIST | 2.5 years | |
| Secondary | Clinical Benefit Rate (CBR) | Response assessed by RECIST v1.1 and iRECIST | 2.5 years | |
| Secondary | Progression Free Survival (PFS) | Time from start of treatment to date of the first documented progression or death in months | 2.5 years | |
| Secondary | Duration of Response (DOR) | Response assessed by RECIST v1.1 and iRECIST | 2.5 years | |
| Secondary | Characterization of tumor-infiltrating lymphocytes by IHC | Change from baseline in TILs by immunohistochemistry (IHC) (such as CD8). | 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) |