The goal of this clinical trial is to learn if N17350 works to treat advanced solid tumors in adults. It will also learn about the safety of N17350 and help determine the best dose to use in future studies.
The main questions it aims to answer are:
1. Does N17350 cause tumors to shrink or stop growing in some participants with advanced solid tumors?
2. Are there any side effects for participants when taking N17350?
3. What is the safest dose of N17350 and the dose that should be used for further study?
4. Researchers will give N17350 directly into tumor lesions using a needle (intratumoral injection). This is an open-label study, meaning all participants will receive N17350 and there is no placebo.
Participants will:
1. Receive injections of N17350 into tumor lesions every second week for 8 or 12 weeks
2. Visit the clinic regularly for checkups, blood tests, and monitoring for side effects
3. Have imaging scans (such as CT or MRI) to measure tumors and assess response
4. Provide blood samples and, when required, tumor samples to help researchers understand how N17350 affects the tumor and the immune system
Who can participate
Age range
18 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
. Age ≥18 years (or legal age of consent in the study jurisdiction).
. Able to provide written informed consent and willing/able to comply with study procedures, visits, and follow-up.
. Advanced solid tumor malignancy (excluding lymphoma and other hematologic malignancies), with disease that has progressed on, is intolerant of, or is ineligible for standard therapies known to provide clinical benefit, or for whom no standard therapy is available.
. ECOG performance status 0-1.
. Measurable disease per IT-RECIST (Parts A1/A2) and RECIST v1.1 (Part A3), as applicable.
. At least one injectable tumor lesion, meeting superficial or visceral criteria and deemed safe/accessible for injection:
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
Phase 1: Safety and tolerability of intratumoral N17350, including incidence of DLTs and adverse events
Timeframe: DLTs: First 28 days; TEAEs/SAEs/laboratory abnormalities: From enrollment through 30 days after last dose assessed up to 4 months
2
Phase 2: Objective Response Rate (ORR) of lesions at RP2D/optimal dose(s)
Timeframe: From baseline disease assessment until disease progression or initiation of a new anticancer therapy, assessed up to 15 months
. Superficial lesions: ≥10 mm in longest diameter (or multiple lesions each ≥5 mm with aggregate longest diameter ≥10 mm), and ≤80 mm, accessible for direct injection (± ultrasound guidance).
. Visceral lesions: ≥10 mm and ≤50 mm in longest diameter, accessible for direct injection.
Exclusion criteria
. Serious psychiatric, medical, or other condition that would interfere with study participation or protocol procedures, in the investigator's judgment.
. History of solid organ transplant.
. Alpha-1 antitrypsin deficiency.
. Hereditary or acquired bleeding disorder/coagulation factor deficiency.
. Active autoimmune disease requiring systemic treatment within the past 6 months, except clinically stable autoimmune conditions in remission not requiring systemic therapy (per protocol).
. Baseline QTcF \>480 ms.
. Pregnant or breastfeeding.
. Prior severe immune-mediated adverse event (imAE) from immunotherapy: ≥Grade 3 imAE within the past 16 weeks, any Grade 4 life-threatening imAE, or any neurologic/ocular AE of any grade (except controlled endocrine AEs on stable replacement therapy per protocol).