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

NCT04676633 ↗

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

EvaluationDrugModalityDoseRoute
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