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SPI-1620 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SPI-1620 | EXPERIMENTAL | SPI-1620 an endothelin B agonist |
| Name | Type | Description |
|---|---|---|
| SPI-1620 | DRUG | SPI-1620 in escalating doses from 0.5 μg/m2 intravenous over sixty seconds |
Inclusion Criteria: All of the following inclusion criteria must be met prior to participation in this study 1. The patient must sign an informed consent. A signed consent form is required prior to the performance of any protocol-related procedures or assessments. 2. The patient must be \>= 18 yea...
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SPI-1620 is an investigational small molecule being studied in patients with recurrent or progressive carcinoma. It was evaluated in a Phase 1 trial as a potential treatment for this solid tumor setting. It is not approved for any indication and remains in clinical development.
SPI-1620 is an endothelin B receptor agonist. By activating the endothelin B receptor, it acts on a molecular target involved in tumor blood flow regulation. This mechanism was explored in a Phase 1 study of patients with recurrent or progressive carcinoma.
SPI-1620 is being developed by Assertio Holdings, Inc., which trades under the ticker ASRT. The company sponsored the Phase 1 clinical program for the drug in oncology.
SPI-1620 is in Phase 1 development. Its single clinical trial, NCT00613691, has been completed. The drug is investigational and has not been approved by the FDA for any indication.
SPI-1620 has been studied in one clinical trial, NCT00613691, titled a Phase I, Open-label, Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Endothelin B Agonist, SPI-1620, in Patients With Recurrent or Progressive Carcinoma. The trial enrolled 36 patients in the United States and is completed.