drugset / Trial / NCT05848739
A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an open-label, two-part, phase 1-2 study designed to determine the safety, tolerability, PK, pharmacodynamics (PD), and proof-of-concept efficacy of ST316 administered IV in subjects with selected advanced solid tumors likely to harbor abnormalities of the WNT/β-catenin signaling pathway. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.
Timeline
- Start
- 2023-06-05
- Primary completion
- 2026-05-31
- Completion
- 2027-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | — |
| Subject | Fruquintinib | Small molecule | 5 mg | — |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Subject | ST316 | Unknown | 0.5 mg/kg | Intravenous |
| Subject | ST316 | Unknown | 1 mg/kg | Intravenous |
| Subject | ST316 | Unknown | 2 mg/kg | Intravenous |
| Subject | ST316 | Unknown | 4 mg/kg | Intravenous |
| Subject | ST316 | Unknown | 8 mg/kg | Intravenous |
| Subject | ST316 | Unknown | 12 mg/kg | Intravenous |
| Subject | TAS-102 | Small molecule | 35 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |