A Clinical Trial Assessing the Safety and Efficacy of Intravenous HNF4α SrRNA for the Treatment of Patients with Metastatic Colorectal Cancer
This trial is a single-arm, open-label, exploratory first-in-human clinical study designed to evaluate the safety and tolerability of HNF4α srRNA injection in patients with locally unresectable or metastatic colorectal cancer, and to preliminarily explore its effectiveness in treating metastatic colorectal cancer.
A Clinical Trial Assessing the Safety and Efficacy of Intravenous HNF4α srRNA for the Treatment of Patients With Advanced Intrahepatic Cholangiocarcinoma
The goal of this investigator-initiated, a single-arm, open-label, pilot study is to investigate the safety, tolerability, and efficacy of intravenous HNF4α srRNA treatment in subjects with advanced Intrahepatic Cholangiocarcinoma (ICC).
Condition of disease: advanced intrahepatic cholangiocarcinoma Intervention： HNF4α srRNA will be administered intravenously for the treatment of ICC. The dosing regimen is planned for a second dose 14 ± 3 days post-initial treatment, followed by subsequent treatments every 28 ± 7 days, with adjustments made based on patient tolerance and therapeutic response. This is a dose escalation assay employing a i3+3 design to assess escalating HNF4α srRNA dosages: 25 μg, 50 μg, and 100 μg. Post-initial dose, a 14-day dose-limiting toxicities (DLT) observation will evaluate tolerability and safety, guiding dose adjustments or selection of the Recommended Dose (RD) for the expansion phase. Cohorts may include up to 9 participants, adjusted for safety.
Drug: HNF4α srRNA, a drug specifically designed to target liver cancer cells and facilitate the expression of HNF4α.
100 项与 HNF4α srRNA 相关的临床结果
100 项与 HNF4α srRNA 相关的转化医学
100 项与 HNF4α srRNA 相关的专利（医药）
100 项与 HNF4α srRNA 相关的药物交易
