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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 being studied for the treatment of non-breast HER2+ malignancies, which are cancers that test positive for the HER2 protein but do not originate in the breast. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
NJH395 is designed to target HER2-positive cancers. It is being evaluated in patients with non-breast HER2+ malignancies, meaning tumors that express the HER2 protein but are not breast cancers. The drug's mechanism involves addressing cancers that have this specific biomarker.
NJH395 is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the safety and dosing of this investigational drug in patients with advanced cancer.
NJH395 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies. The Phase 1 trial has been completed, and the drug is no longer in active clinical testing according to available trial records.
NJH395 has been studied in one clinical trial with the identifier NCT03696771. This Phase 1 study, titled 'Study to Determine Safety and Dose of NJH395 in Non-breast HER2+ Advanced Cancer,' was completed and enrolled 18 participants. The trial was conducted in the United States, Italy, Japan, and South Korea.
NJH395 is a distinct investigational drug candidate developed by Novartis. It is not known to be the same as any other approved or marketed medication. Its unique identifier is NJH395, and it is being studied specifically for non-breast HER2+ malignancies.