drugset / Trial / NCT07583914

Safety, Tolerability, and Preliminary Antitumor Activity of Non-Cationic Peptide-CD47 siRNA in Advanced Solid Tumors

NCT07583914 ↗

Phase 1 Not yet recruiting 9 enrolled West China Hospital
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study evaluates a non-cationic peptide-CD47 siRNA nanocomplex for refractory advanced solid tumors. The candidate blocks the CD47-SIRPα "don't eat me" signal, repolarizes tumor-associated macrophages, and restores antitumor immunity. Using a 3+3 dose-escalation design (25, 50, 100 μg), the investigators aim to define the MTD and RP2D, providing a novel therapeutic approach and clinical evidence for siRNA drug development.

Timeline

Start
2026-05-30
Primary completion
2027-06-30
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject NCP-CD47 siRNA Small interfering RNA (siRNA) 25 ug Other
Subject NCP-CD47 siRNA Small interfering RNA (siRNA) 50 ug Other
Subject NCP-CD47 siRNA Small interfering RNA (siRNA) 100 ug Other