Actively Recruiting
A Phase 1/2 Open-Label, Dose Finding and Expansion Study to Investigate the Safety and Effectiveness and Determination of the Optimal Dose of N17350 Administered Intratumorally in Participants With Advanced Solid Tumors
Led by Onchilles Pharma Inc · Updated on 2026-05-14
275
Participants Needed
1
Research Sites
69 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
Researchers are studying N17350, an investigational medicine given by injection directly into tumor lesions, in adults with advanced solid tumors that have spread or cannot be removed by surgery. The study aims to find out if N17350 can shrink or stop tumor growth, determine the safest dose, and understand any side effects. This open-label Phase 1/2 trial includes participants whose tumors no longer respond to standard treatments or who have no available options. Participants will receive N17350 injections into accessible tumor lesions every two weeks for 8 or 12 weeks. The study has two parts: a dose-finding phase where small groups receive different doses to assess safety and find the best dose, followed by a dose expansion phase to further evaluate safety and treatment effects. Different doses will be given depending on the tumor type and location, including superficial and visceral lesions. During the study, participants will attend regular clinic visits for treatment, safety checks, and monitoring. Assessments include physical exams, blood and urine tests, heart monitoring if needed, and imaging scans like CT or MRI to measure tumor response. Researchers will also collect blood and tumor samples to study how N17350 affects the tumor and immune system. The main outcomes include safety, dose recommendations, tumor response, and biological changes, with follow-up up to 15 months.
CONDITIONS
Brief 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 jurisdiction)
- Able to provide written informed consent and willing/able to comply with study procedures, visits, and follow-up
- Diagnosed with advanced solid tumor malignancy (excluding lymphoma and hematologic cancers) with disease progression or intolerance to standard therapies
- ECOG performance status of 0 or 1
- Measurable disease per IT-RECIST or RECIST v1.1 criteria
- At least one injectable tumor lesion meeting size and safety criteria for superficial or visceral lesions
- Recovery from prior therapy toxicities to Grade 1 or baseline except allowed exceptions
- Adequate organ function including liver, kidney, and coagulation parameters
- Adequate bone marrow function without recent transfusion within 7 days
- Willingness to provide tumor biopsy samples as required
- Use of effective contraception and negative pregnancy test for women of childbearing potential
You will not qualify if you...
- Serious psychiatric, medical, or other condition interfering with participation
- History of solid organ transplant
- Alpha-1 antitrypsin deficiency
- Bleeding disorders or coagulation factor deficiencies
- Active autoimmune disease requiring systemic treatment within past 6 months except stable remission cases
- Baseline QTcF over 480 ms
- Pregnant or breastfeeding
- Prior severe immune-mediated adverse events from immunotherapy within recent weeks
- Another active malignancy within past 2 years except certain treated low-risk cancers
- Recent anticancer therapy within 2 to 4 weeks depending on treatment type
- Recent radiotherapy within 2 weeks prior to first dose
- Unresolved toxicity from prior therapy over Grade 1 except specified exceptions
- Uncontrolled or unstable brain metastases
- Active infections needing systemic antimicrobial therapy within 14 days
- Chronic viral infections not meeting protocol criteria
- Use of systemic anticoagulants within 14 days
- Use of systemic corticosteroids or immunosuppressive medications within 4 weeks except allowed exceptions
- Known allergy or hypersensitivity to N17350 or its ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 to 12 weeks
Participants receive N17350 injections directly into tumor lesions every two weeks. Treatment lasts for 8 to 12 weeks depending on the participant's assigned dose and tumor type.
Weekly visits for treatment administration every 2 weeks
Duration - Up to 15 months
Participants undergo safety evaluations and tumor assessments to monitor response to treatment and side effects continuing after the last dose.
Periodic visits for safety and tumor response assessments
Trial Site Locations
Total: 1 location
1
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
Research Team
O
Onchilles Pharma Clinical Trials
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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