At a glance
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A Phase I, Open-Label, Single-Arm Study to Evaluate the Safety, Tolerability, and Preliminary Anti-Tumor Activity of Non-Cationic Peptide-IL-22BP mRNA (NCP-IL-22BP mRNA) in Patients With Advanced Malignant Solid Tumors
In Brief
A Phase 1 clinical trial evaluating 25 μg NCP-IL-22BP mRNA, 50 μg NCP-IL-22BP mRNA, and 1 other intervention for Cancer. Not yet recruiting, targeting 9 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
NCP-IL-22BP mRNA administered by intratumoral injection, 5 doses at weekly intervals
NCP-IL-22BP mRNA administered by intratumoral injection, 5 doses at weekly intervals
NCP-IL-22BP mRNA administered by intratumoral injection, 5 doses at weekly intervals