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NJH395 · 1 trial · 1 indication
The time frame will expand to 42 days for the second part of the study
| Arm | Type | Description |
|---|---|---|
| NJH395 | EXPERIMENTAL | Includes non-breast HER2-positive advanced malignancies |
| Name | Type | Description |
|---|---|---|
| NJH395 | DRUG | Immune stimulator antibody conjugate (ISAC), consisting of a monoclonal antibody which targets HER2 conjugated to an immune-stimulatory agent |
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 ...
NJH395 is an investigational small molecule developed by Novartis AG for NON-breast HER2+ malignancies. It is an oncology candidate that has been studied in a Phase 1 clinical trial. NJH395 is not approved and remains in clinical development.
NJH395 is being studied for NON-breast HER2+ malignancies, meaning HER2-positive cancers outside of breast cancer. It is an oncology candidate and is not approved for any use. Its only clinical study enrolled adults with advanced HER2-positive non-breast tumors.
NJH395 is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the Phase 1 study of NJH395 in NON-breast HER2+ malignancies.
NJH395 is in Phase 1 development. Its single clinical trial, NCT03696771, has been completed. NJH395 is investigational and has not been approved by the FDA for any indication.
NJH395 has been studied in one Phase 1 trial, NCT03696771, titled Study to Determine Safety and Dose of NJH395 in Non-breast HER2+ Advanced Cancer. The trial was completed and enrolled 18 participants across the United States, Italy, Japan, and South Korea.
The NJH395 Phase 1 trial NCT03696771 was an uncontrolled, non-randomized, open-label study. It enrolled 18 adults aged 18 years and older with NON-breast HER2+ malignancies and assessed safety and dose. The study was completed and included sites in the United States, Italy, Japan, and South Korea.