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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Dose-Limiting Toxicities
Timeframe: From the first dose to 3 weeks post-dose. (approximately 3 weeks)