Safety and Tolerability of NCP-IL-22BP mRNA in Advanced Solid Tumors (NCT07562815) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety and Tolerability of NCP-IL-22BP mRNA in Advanced Solid Tumors
China9 participantsStarted 2026-04-28
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female patients aged ≥18 and ≤70 years
✓. Histopathologically confirmed advanced recurrent/metastatic malignant solid tumors that have failed second-line therapy with no standard treatment options available (e.g., advanced soft tissue sarcoma, head and neck squamous cell carcinoma, malignant melanoma)
✓. ECOG Performance Status score: 0-1
✓. Estimated life expectancy ≥3 months
✓. At least 28 days since prior chemotherapy, radiotherapy, or surgery
✓. At least 6 weeks since prior use of nitrosoureas or mitomycin C
✓. Adequate organ function within 14 days prior to enrollment:
✓. Signed written informed consent
Exclusion criteria
✕. Participation in another clinical drug trial within 4 weeks
✕
What they're measuring
1
Incidence of Dose-Limiting Toxicities
Timeframe: From the first dose to 3 weeks post-dose. (approximately 3 weeks)