drugset / Trial / NCT04720664
Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is a phase II single arm, open-label study of SM-88 used with methoxsalen, phenytoin, and sirolimus (MPS) in metastatic HR+/HER2- breast cancer. It is designed to determine efficacy, defined as the objective response rate (ORR) of this investigational treatment. It is hypothesized that SM-88 used with MPS will lead to significant anti-tumor responses with acceptable toxicities in patients with metastatic HR+/HER2- breast cancer.
Timeline
- Start
- 2021-09-22
- Primary completion
- 2023-02-10
- Completion
- 2023-02-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SM-88 | Unknown | 460 mg | Oral |
| Background | Methoxsalen | Other / unclassified | 10 mg | Oral |
| Background | Phenytoin | Unknown | 50 mg | Oral |
| Background | Sirolimus | Small molecule | 0.5 mg | Oral |