drugset / Trial / NCT04478279
A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an open-label, two-part, phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 administered IV in patients with advanced solid tumors. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.
Timeline
- Start
- 2020-07-01
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ISMIDENON | Small molecule | 0.5 mg/kg | Intravenous |
| Subject | ISMIDENON | Small molecule | 1 mg/kg | Intravenous |
| Subject | ISMIDENON | Small molecule | 2 mg/kg | Intravenous |
| Subject | ISMIDENON | Small molecule | 4 mg/kg | Intravenous |
| Subject | ISMIDENON | Small molecule | 8 mg/kg | Intravenous |
| Subject | ISMIDENON | Small molecule | 16 mg/kg | Intravenous |
| Background | Temozolomide | Small molecule | — | — |