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

Sponsor
West China Hospital
Study ID
NCT07583914
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • NCP-CD47 siRNA intratumorally injection — BIOLOGICAL
    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.

Study Details

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.

Key Dates

First listed
May 13, 2026
Start date
May 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
9 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intratumoral NCP-CD47 siRNA injection group

Primary Outcome Measure

Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) [ Time Frame: From the first dose to the end of treatment at 9 weeks ]

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