Safety, Tolerability, and Preliminary Antitumor Activity of Non-Cationic Peptide-CD47 siRNA in Advanced Solid Tumors
NCT07583914 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2026-05-13
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.
Conditions
- Solid Tumor Cancer
- Metastases
- Head and Neck Cancer
Interventions
- BIOLOGICAL
-
NCP-CD47 siRNA intratumorally injection
NCP-CD47 siRNA will be administered via intratumoral injection. A total of 5 doses will be given, with subsequent doses administered once weekly after the first injection.
Sponsors & Collaborators
-
West China Hospital
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-30
- Primary Completion
- 2027-06-30
- Completion
- 2027-12-30
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