Actively Recruiting
Intratumoral N17350 in Advanced Solid Tumors
Led by Onchilles Pharma Inc · Updated on 2026-05-14
275
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
O
Onchilles Pharma Inc
Lead Sponsor
O
Onchilles Pharma Pty Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Intratumoral N17350 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older (or legal age of consent in the study location)
- Able to give informed consent and willing to follow study procedures and visits
- Have advanced solid tumor cancer that has progressed on or is not suitable for standard therapies
- ECOG performance status of 0 or 1
- Have measurable disease according to IT-RECIST or RECIST v1.1 criteria
- Have at least one injectable tumor lesion suitable for injection and safe to treat
- Recovered adequately from prior cancer treatments with resolved toxicities to Grade 1 or baseline (except certain stable toxicities)
- Have adequate liver, kidney, coagulation, and bone marrow function per study requirements
- Willing to provide pre-treatment and on-treatment tumor biopsies if safe and available, or provide archival tumor tissue
- Agree to use effective contraception and avoid pregnancy/fathering children during the study and 30 days after last dose; women of childbearing potential must have a negative pregnancy test within 14 days prior to first dose
You will not qualify if you...
- Serious psychiatric, medical, or other conditions that could interfere with study participation
- History of solid organ transplant
- Alpha-1 antitrypsin deficiency
- Bleeding or coagulation disorders
- Active autoimmune disease requiring systemic treatment within past 6 months, except stable conditions
- Baseline QTcF greater than 480 ms
- Pregnant or breastfeeding
- Prior severe immune-related adverse events from immunotherapy within specified timeframes
- Another active cancer within past 2 years except certain low-risk cancers
- Recent anticancer therapy within specified timeframes
- Recent radiotherapy within 2 weeks prior to first dose
- Unresolved toxicities from prior treatments above Grade 1 except allowed exceptions
- Uncontrolled or unstable brain metastases unless stable for at least 4 weeks and off or on stable steroids
- Active infections requiring systemic treatment within 14 days prior to first dose
- Chronic viral infections not meeting protocol criteria (HBV, HCV, HIV)
- Use of systemic anticoagulants within 14 days prior to first dose
- Use of systemic corticosteroids or immunosuppressants above specified doses within 4 weeks prior to first dose except permitted exceptions
- Known allergy or hypersensitivity to N17350 or its components
AI-Screening
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Trial Site Locations
Total: 1 location
1
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
Research Team
O
Onchilles Pharma Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
10
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