drugset / Trial / NCT04676633
Safety, Tolerability, PK, Anti-Tumor Activity of STP705 in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy
RandomizedSequentialOpen-labelTreatment
Summary
This is an open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of STP705 administered intratumorally in cholangiocarcinoma, hepatocellular carcinoma or liver metastasis in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy. Goals: 1. To determine the MTD or RP2D of STP705 when administered intratumorally into cholangiocarcinoma, hepatocellular carcinoma, or liver metastasis. 2. To establish the dose of STP705 recommended for future phase 2 studies when administered intratumorally.
Timeline
- Start
- 2021-03-01
- Primary completion
- 2023-01-13
- Completion
- 2023-01-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | STP705 | Small interfering RNA (siRNA) | 20 ug | Other |
| Subject | STP705 | Small interfering RNA (siRNA) | 40 ug | Other |
| Subject | STP705 | Small interfering RNA (siRNA) | 80 ug | Other |
| Subject | STP705 | Small interfering RNA (siRNA) | 160 ug | Other |
| Subject | STP705 | Small interfering RNA (siRNA) | 320 ug | Other |