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Safety and Tolerability of NCP-IL-22BP mRNA in Advanced Solid Tumors

NCT07562815 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-05-11

No results posted yet for this study

Summary

This is a phase I, open-label, single-arm, single-center, dose-escalation study to evaluate the safety, tolerability, and preliminary anti-tumor activity of NCP-IL-22BP mRNA, a non-cationic peptide-delivered mRNA encoding interleukin-22 binding protein (IL-22BP), administered by intratumoral injection in patients with advanced malignant solid tumors who have failed second-line therapy. The study employs a classical "3+3" dose-escalation design with three dose levels (25 μg, 50 μg, and 100 μg mRNA). Each subject will receive 5 doses at weekly intervals. The primary objective is to assess the safety and tolerability of NCP-IL-22BP mRNA, and the secondary objective is to evaluate its preliminary anti-tumor activity.

Conditions

Interventions

BIOLOGICAL

25 μg NCP-IL-22BP mRNA

NCP-IL-22BP mRNA administered by intratumoral injection, 5 doses at weekly intervals

BIOLOGICAL

50 μg NCP-IL-22BP mRNA

NCP-IL-22BP mRNA administered by intratumoral injection, 5 doses at weekly intervals

BIOLOGICAL

100 μg NCP-IL-22BP mRNA

NCP-IL-22BP mRNA administered by intratumoral injection, 5 doses at weekly intervals

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Xingchen Peng · The West China Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-28
Primary Completion
2027-04-28
Completion
2027-12-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07562815 on ClinicalTrials.gov