Neoplasms, Solid TumorPhase 1/2OP-NEU-101NCT07339176
Intratumoral N17350 in Advanced Solid Tumors
A Phase 1/2 study testing N17350 in people with Neoplasms, Solid Tumor and Breast Neoplasms, Triple-Negative, run by Onchilles Pharma Inc at 9 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Solid Tumor, Breast Neoplasms, Triple-Negative, Squamous Cell Carcinoma of Skin
- What is being tested?
- N17350
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 25 May 2026to Nov 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
- Injected lesions must not involve/encase major blood vessels or otherwise pose an unacceptable bleeding/vascular risk, per investigator assessment and imaging review (as applicable).
- Expansion (Part A3): at least 1 measurable lesion and at least 1 additional injectable lesion suitable for injection.
- Adequate recovery from prior therapy: toxicities from prior anticancer treatment resolved to Grade ≤1 or baseline (except alopecia, controlled endocrine toxicities, or other stable toxicities as allowed per protocol/sponsor).
- Adequate organ function, including hepatic, renal, and coagulation parameters per protocol-defined thresholds.
- Adequate bone marrow function without transfusion support within 7 days prior to enrollment, per protocol-defined thresholds.
- Tumor tissue requirements: willingness to provide a pre-treatment tumor biopsy and on-study post-treatment biopsy, if an accessible lesion is available and safe for biopsy, and biopsy does not interfere with injection/response assessment; and/or availability of archival tumor tissue (obtained within 2 years prior to treatment), per protocol.
- Contraception requirements: participants of reproductive potential agree to use effective contraception and avoid pregnancy/fathering children from screening through 30 days after last dose; women of childbearing potential must have a negative pregnancy test within 14 days prior to first dose, per protocol.
Who cannot join
- 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.
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- 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).
- Another active malignancy (current or within the past 2 years) other than the disease under study, except specified low-risk cancers treated with curative intent or under active surveillance (per protocol).
- Recent anticancer therapy: receipt of systemic anticancer therapy (including investigational agents) within 2 weeks prior to first dose (or 4 weeks for monoclonal antibodies/ADCs/other long half-life biologics), or within 5 half-lives, whichever is shorter.
- Recent radiotherapy within 2 weeks prior to first dose.
- Unresolved toxicity from prior anticancer therapy to >Grade 1 or not at baseline (except Grade ≤2 neuropathy and other allowed exceptions per protocol).
- Uncontrolled or unstable brain metastases (eligible only if neurologically stable for ≥4 weeks, and off steroids or on stable/decreasing steroids ≤10 mg/day prednisone equivalent; carcinomatous meningitis excluded).
- Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose.
- Chronic viral infections not meeting protocol criteria:
- HBV with detectable DNA unless on appropriate antiviral therapy
- Active HCV with detectable HCV RNA (treated HCV permitted if RNA undetectable)
- HIV infection with CD4+ count <300/μL, detectable viral load, or HIV-related illness within 6 months
- Use of systemic anticoagulants (e.g., warfarin, LMWH, DOACs) within 14 days prior to first dose.
- Chronic systemic corticosteroids >10 mg/day prednisone equivalent, or systemic immunosuppressive/anti-inflammatory medications within 4 weeks prior to first dose, except permitted topical/inhaled/local formulations or short courses for premedication per protocol.
- Known allergy/hypersensitivity to N17350 or any excipients.
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
United States6 sites, 6 recruiting
- Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Patient Referral Hotline, 1-800-ROSWELL, Benjamin.Switzer@roswellpark.org
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Nan Xin, 713-822-0660, Nxin@mdanderson.org
- Not yet recruiting
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
Saba Mukarram, 310-231-2181, SMukarram@theangelesclinic.org
- Recruiting
UCLA - Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Adyel Annelus, 310-794-4955, AAnnelus@mednet.ucla.edu
- Recruiting
Scripps Clinic Torrey Pines - La Jolla
San Diego, California, 92037
Dr Jacob New, 858-554-8788, CRSLeadership@scrippshealth.org
- Not yet recruiting
University of California, San Francisco
San Francisco, California, 94143
Sonia Contreras Martinez, 415-714-4484, Sonia.ContrerasMartinez@ucsf.edu
Australia3 sites, 3 recruiting
- Recruiting
Peter MacCallum Cancer Centre (PMCC)
Melbourne, Victoria, 3550
Dr Annette Lim, +61 3 8559 5000, PCCTU.EDD@petermac.org
- Recruiting
Calvary Mater Hospital
Newcastle, New South Wales, 2298
Dr Jordan Cohen, +61 240143562, Jordan.Cohen@health.nsw.gov.au
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Westmead Clinical Trials, +61 2-8890-5200, Matteo.carlino@sydney.edu.au
About this study
Official title: 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
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:
Read more
- Does N17350 cause tumors to shrink or stop growing in some participants with advanced solid tumors?
- Are there any side effects for participants when taking N17350?
- What is the safest dose of N17350 and the dose that should be used for further study?
- 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:
- Receive injections of N17350 into tumor lesions every second week for 8 or 12 weeks
- Visit the clinic regularly for checkups, blood tests, and monitoring for side effects
- Have imaging scans (such as CT or MRI) to measure tumors and assess response
- Provide blood samples and, when required, tumor samples to help researchers understand how N17350 affects the tumor and the immune system
Read the detailed description
This is a Phase 1/2 clinical study evaluating an investigational medicine called N17350 in adults with advanced solid tumors that have spread or cannot be removed by surgery and for which standard treatment options are no longer working, are not available, or are not appropriate.
N17350 will be administered by injection directly into tumor lesions (intratumoral injection). Giving N17350 into the tumor is intended to deliver treatment to the cancer site and may help stimulate an immune response against the tumor.
This is an open-label study, meaning all participants will receive N17350 and both participants and the study team will know the treatment being given. The study is designed to evaluate safety, identify an optimal dose, and look for early signs of anti-tumor activity.
Study Parts
The study includes two parts:
Part 1: Dose Finding (Phase 1) Small groups of participants will receive different dose levels of N17350. The main purpose is to understand how safe N17350 is and to determine a dose that can be given safely and is suitable for further study. Safety information from participants will be reviewed as dose levels are increased or adjusted.
Part 2: Dose Expansion (Phase 2) After a dose is selected from Part 1, additional participants will receive N17350 at that dose. This part is designed to better understand safety at the selected dose and to further evaluate how well N17350 may work in participants with advanced solid tumors. Depending on the study plan, expansion may include groups of participants with specific tumor types.
Treatment and Visits
Participants will receive N17350 injections into tumor lesions every second week for 8 or 12 weeks. Participants will attend clinic visits for treatment administration and ongoing monitoring.
Throughout the study, participants will undergo safety evaluations, which may include:
Review of side effects and other medical problems Physical examinations and vital signs Blood and urine tests Heart monitoring (such as ECG), if required Review of medications and overall health status
Participants will also undergo evaluations to measure how their cancer responds to treatment, which may include:
Imaging scans (such as CT or MRI) to measure tumors over time Clinical assessments of injected lesions and other tumor sites
Biomarker and Research Samples
The study may include collection of blood samples and, when required, tumor samples to help researchers understand how N17350 affects the tumor and the immune system. These samples may be used to study markers of immune activation and other biological changes that could be associated with response or side effects.
Outcomes and Goals
The main goals of the study are to:
Determine the type and frequency of side effects and evaluate overall safety
Identify a recommended dose and dosing approach for future studies
Evaluate early signs of treatment activity, such as tumor shrinkage, stable disease, or delayed tumor growth
Explore biological changes in blood and tumor tissue that may help explain how N17350 works
Study Hypothesis
The study hypothesis is that N17350 can be administered safely by intratumoral injection at doses that are tolerable, and that treatment may lead to anti-tumor effects in some participants with advanced solid tumors, potentially by helping the immune system recognize and attack cancer cells.
- Conditions
- Neoplasms, Solid Tumor, Breast Neoplasms, Triple-Negative, Squamous Cell Carcinoma of Skin, Melanoma, Head and Neck Neoplasms, Carcinoma, Squamous Cell
- Being tested
- N17350
- Keywords
- N17350, Intratumoral injection, Intralesional injection, Dose escalation, Dose finding, Dose expansion, Phase 1, Open-label, Safety, Tolerability, Biomarkers, Advanced solid tumors, Triple-negative breast cancer, Cutaneous squamous cell carcinoma, Melanoma, Head and neck squamous cell carcinoma, Non-small cell lung cancer, OP-NEU-101, Onchilles, Onchilles Pharma
- Medical subject headings
- Neoplasms, Triple Negative Breast Neoplasms, Melanoma, Head and Neck Neoplasms, Carcinoma, Squamous Cell, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N17350Biological
N17350 is a recombinant mutant porcine pancreatic elastase (PPE) developed to target the neutrophil elastase (ELANE) pathway.
| Study group | Role | What they receive |
|---|---|---|
| N17350 Intratumoral Injection 1 mg/ml superficial lesions | Experimental | Participants with superficial lesions will receive 1 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks. Receives: Biological: N17350 |
| N17350 Intratumoral Injection 2 mg/ml superficial lesions | Experimental | Participants with superficial lesions will receive 2 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks. Receives: Biological: N17350 |
| N17350 Intratumoral Injection 4 mg/ml superficial lesions | Experimental | Participants with superficial lesions will receive 4 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks. Receives: Biological: N17350 |
| N17350 Intratumoral Injection 2 mg/ml visceral lesions | Experimental | Participants with visceral lesions will receive 2 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks. Receives: Biological: N17350 |
| N17350 Intratumoral Injection 4 mg/ml visceral lesions | Experimental | Participants with visceral lesions will receive 4 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks. Receives: Biological: N17350 |
| N17350 Intratumoral Injection for cuSCC | Experimental | Participants with cuSCC superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose. Receives: Biological: N17350 |
| N17350 Intratumoral Injection for Melanoma | Experimental | Participants with Melanoma superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose. Receives: Biological: N17350 |
| N17350 Intratumoral Injection for SCCHN | Experimental | Participants with SCCHN superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose. Receives: Biological: N17350 |
| N17350 Intratumoral Injection for NSCLC | Experimental | Participants with NSCLC superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose. Receives: Biological: N17350 |
| N17350 Intratumoral Injection for TNBC | Experimental | Participants with TNBC superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose. Receives: Biological: N17350 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Safety and tolerability of intratumoral N17350, including incidence of DLTs and adverse events
Safety and tolerability will be assessed by the incidence and severity of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), and by laboratory abnormalities graded per CTCAE
Measured: DLTs: First 28 days; TEAEs/SAEs/laboratory abnormalities: From enrollment through 30 days after last dose assessed up to 4 months
Phase 2: Objective Response Rate (ORR) of lesions at RP2D/optimal dose(s)
ORR is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) in superficial and/or visceral lesions, assessed in separate tumor-specific expansion cohorts at the selected optimal dose(s)/RP2D(s), per protocol-defined response criteria
Measured: From baseline disease assessment until disease progression or initiation of a new anticancer therapy, assessed up to 15 months
Secondary outcomes (11)
Objective Response Rate (ORR) in lesions (Phase 1)
ORR is defined as the proportion of participants with a best overall response of CR or PR in superficial and visceral lesions, assessed during dose escalation and backfill cohorts per RECIST v1.1 and/or IT-RECIST, as applicable
Measured: From first dose through end of treatment (up to 12 weeks) and follow-up tumor assessments, assessed up to 12 months
Systemic exposure (PK) of N17350 following intratumoral administration
Systemic exposure to N17350 will be assessed by serum concentrations of active and inactive N17350
Measured: From first dose through 30 days after last dose, assessed up to 4 months.
Systemic exposure (PK) of N17350 following intratumoral administration
Systemic exposure to N17350 will be assessed by serum concentrations of N17350, and derived PK parameter of Cmax
Measured: From first dose through 30 days after last dose, assessed up to 4 months.
Systemic exposure (PK) of N17350 following intratumoral administration
Systemic exposure to N17350 will be assessed by serum concentrations of N17350, and derived PK parameter of Tmax
Measured: From first dose through 30 days after last dose, assessed up to 4 months.
Systemic exposure (PK) of N17350 following intratumoral administration
Systemic exposure to N17350 will be assessed by serum concentrations of N17350, and derived PK parameter of area under the curve (AUC)
Measured: From first dose through 30 days after last dose, assessed up to 4 months.
Systemic exposure (PK) of N17350 following intratumoral administration
Systemic exposure to N17350 will be assessed by serum concentrations of N17350, and derived PK parameter of N17350 half life
Measured: From first dose through 30 days after last dose, assessed up to 4 months.
Immunogenicity of N17350 (anti-drug antibodies [ADA])
Immunogenicity will be assessed by the incidence and titers of anti-drug antibodies (ADA) to N17350
Measured: From first dose through 30 days after last dose, assessed up to 4 months
Preliminary antitumor activity in lesions (ORR, DOR, DCR, CBR)
Antitumor activity in superficial and visceral lesions will be assessed by:
Objective Response Rate (ORR): proportion of participants with best overall response of CR or PR
Duration of Response (DOR): time from first documented response (CR or PR) to disease progression or death
Disease Control Rate (DCR): proportion of participants with best overall response of CR, PR, or SD
Clinical Benefit Rate (CBR): proportion of participants with CR, PR, or durable SD (as defined in the protocol)
Responses will be assessed per RECIST v1.1 and/or IT-RECIST, as applicable.
Measured: From first dose until disease progression or start of new anticancer therapy, assessed up to 15 months
Pharmacodynamic (PD) biomarkers
Changes from baseline in PD biomarkers measured in blood and/or tumor samples, as applicable, following intratumoral administration of N17350
Measured: From first dose through 30 days after last dose, assessed up to 4 months
Progression-Free Survival (PFS) (Phase 2)
PFS is defined as the time from first dose to disease progression or death from any cause, assessed per RECIST v1.1 and/or IT-RECIST, as applicable
Measured: From first dose until disease progression or death, assessed up to 15 months
Overall Survival (OS) (Phase 2)
OS is defined as the time from first dose to death from any cause.
Measured: From first dose until death, assessed up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start25 May 2026
- Primary completionJul 2028 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a Phase 1/2, open-label, multicenter study of intratumoral N17350 in adults with advanced solid tumors. Phase 1 uses sequential dose escalation to evaluate safety/tolerability and identify a recommended dose based on DLTs and other safety data. Phase 2 enrolls expansion cohorts at the selected dose to further assess safety and preliminary anti-tumor activity in TNBC, cuSCC, melanoma, SCCHN, and NSCLC. N17350 is injected into accessible tumor lesions every 2 weeks for 8 or 12 weeks, with ongoing safety and tumor assessments.
- Masking
- None (open label)
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onchilles Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Onchilles Pharma Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Emily Roberts-Thomson, Study director, Onchilles Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339176
- Sponsor's protocol ID
- OP-NEU-101
- Acronym
- OP-NEU-101
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: An IPD sharing plan has not yet been finalized. Any decision to share individual participant data will be determined after study completion and will consider participant privacy, informed consent, and applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07339176
- Acronym / sponsor ID
- OP-NEU-101 / OP-NEU-101
- Conditions
- Neoplasms, Solid Tumor, Breast Neoplasms, Triple-Negative, Squamous Cell Carcinoma of Skin, Melanoma, Head and Neck Neoplasms, Carcinoma, Squamous Cell
- Keywords
- N17350, Intratumoral injection, Intralesional injection, Dose escalation, Dose finding, Dose expansion, Phase 1, Open-label
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Onchilles Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Onchilles Pharma Pty Ltd
- Study start
- 25 May 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does N17350 cause tumors to shrink or stop growing in some participants with advanced solid tumors?
- Are there any side effects for participants when taking N17350?
- What is the safest dose of N17350 and the dose that should be used for further study?
- 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:
- Receive injections of N17350 into tumor lesions every second week for 8 or 12 weeks
- Visit the clinic regularly for checkups, blood tests, and monitoring for side effects
- Have imaging scans (such as CT or MRI) to measure tumors and assess response
- Provide blood samples and, when required, tumor samples to help researchers understand how N17350 affects the tumor and the immune system
Detailed description
This is a Phase 1/2 clinical study evaluating an investigational medicine called N17350 in adults with advanced solid tumors that have spread or cannot be removed by surgery and for which standard treatment options are no longer working, are not available, or are not appropriate.
N17350 will be administered by injection directly into tumor lesions (intratumoral injection). Giving N17350 into the tumor is intended to deliver treatment to the cancer site and may help stimulate an immune response against the tumor.
This is an open-label study, meaning all participants will receive N17350 and both participants and the study team will know the treatment being given. The study is designed to evaluate safety, identify an optimal dose, and look for early signs of anti-tumor activity.
Study Parts
The study includes two parts:
Part 1: Dose Finding (Phase 1) Small groups of participants will receive different dose levels of N17350. The main purpose is to understand how safe N17350 is and to determine a dose that can be given safely and is suitable for further study. Safety information from participants will be reviewed as dose levels are increased or adjusted.
Part 2: Dose Expansion (Phase 2) After a dose is selected from Part 1, additional participants will receive N17350 at that dose. This part is designed to better understand safety at the selected dose and to further evaluate how well N17350 may work in participants with advanced solid tumors. Depending on the study plan, expansion may include groups of participants with specific tumor types.
Treatment and Visits
Participants will receive N17350 injections into tumor lesions every second week for 8 or 12 weeks. Participants will attend clinic visits for treatment administration and ongoing monitoring.
Throughout the study, participants will undergo safety evaluations, which may include:
Review of side effects and other medical problems Physical examinations and vital signs Blood and urine tests Heart monitoring (such as ECG), if required Review of medications and overall health status
Participants will also undergo evaluations to measure how their cancer responds to treatment, which may include:
Imaging scans (such as CT or MRI) to measure tumors over time Clinical assessments of injected lesions and other tumor sites
Biomarker and Research Samples
The study may include collection of blood samples and, when required, tumor samples to help researchers understand how N17350 affects the tumor and the immune system. These samples may be used to study markers of immune activation and other biological changes that could be associated with response or side effects.
Outcomes and Goals
The main goals of the study are to:
Determine the type and frequency of side effects and evaluate overall safety
Identify a recommended dose and dosing approach for future studies
Evaluate early signs of treatment activity, such as tumor shrinkage, stable disease, or delayed tumor growth
Explore biological changes in blood and tumor tissue that may help explain how N17350 works
Study Hypothesis
The study hypothesis is that N17350 can be administered safely by intratumoral injection at doses that are tolerable, and that treatment may lead to anti-tumor effects in some participants with advanced solid tumors, potentially by helping the immune system recognize and attack cancer cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 10
- Model description
- This is a Phase 1/2, open-label, multicenter study of intratumoral N17350 in adults with advanced solid tumors. Phase 1 uses sequential dose escalation to evaluate safety/tolerability and identify a recommended dose based on DLTs and other safety data. Phase 2 enrolls expansion cohorts at the selected dose to further assess safety and preliminary anti-tumor activity in TNBC, cuSCC, melanoma, SCCHN, and NSCLC. N17350 is injected into accessible tumor lesions every 2 weeks for 8 or 12 weeks, with ongoing safety and tumor assessments.
| Arm | Type | Receives |
|---|---|---|
| N17350 Intratumoral Injection 1 mg/ml superficial lesions | Experimental | Biological: N17350Participants with superficial lesions will receive 1 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks. |
| N17350 Intratumoral Injection 2 mg/ml superficial lesions | Experimental | Biological: N17350Participants with superficial lesions will receive 2 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks. |
| N17350 Intratumoral Injection 4 mg/ml superficial lesions | Experimental | Biological: N17350Participants with superficial lesions will receive 4 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks. |
| N17350 Intratumoral Injection 2 mg/ml visceral lesions | Experimental | Biological: N17350Participants with visceral lesions will receive 2 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks. |
| N17350 Intratumoral Injection 4 mg/ml visceral lesions | Experimental | Biological: N17350Participants with visceral lesions will receive 4 mg/ml intratumoral N17350 injected into accessible tumor lesions every 2 weeks up to 12 weeks. |
| N17350 Intratumoral Injection for cuSCC | Experimental | Biological: N17350Participants with cuSCC superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose. |
| N17350 Intratumoral Injection for Melanoma | Experimental | Biological: N17350Participants with Melanoma superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose. |
| N17350 Intratumoral Injection for SCCHN | Experimental | Biological: N17350Participants with SCCHN superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose. |
| N17350 Intratumoral Injection for NSCLC | Experimental | Biological: N17350Participants with NSCLC superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose. |
| N17350 Intratumoral Injection for TNBC | Experimental | Biological: N17350Participants with TNBC superficial or visceral lesions will receive intratumoral N17350 injected into tumor lesions every 2 weeks up to 12 weeks at the recommended phase two dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N17350N17350 is a recombinant mutant porcine pancreatic elastase (PPE) developed to target the neutrophil elastase (ELANE) pathway. | Biological | N17350 Intratumoral Injection 1 mg/ml superficial lesions, N17350 Intratumoral Injection 2 mg/ml superficial lesions, N17350 Intratumoral Injection 2 mg/ml visceral lesions, N17350 Intratumoral Injection 4 mg/ml superficial lesions, N17350 Intratumoral Injection 4 mg/ml visceral lesions, N17350 Intratumoral Injection for Melanoma, N17350 Intratumoral Injection for NSCLC, N17350 Intratumoral Injection for SCCHN, N17350 Intratumoral Injection for TNBC, N17350 Intratumoral Injection for cuSCC |
Primary outcome
Phase 1: Safety and tolerability of intratumoral N17350, including incidence of DLTs and adverse events
Time frame: DLTs: First 28 days; TEAEs/SAEs/laboratory abnormalities: From enrollment through 30 days after last dose assessed up to 4 months
Safety and tolerability will be assessed by the incidence and severity of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), and by laboratory abnormalities graded per CTCAE
Phase 2: Objective Response Rate (ORR) of lesions at RP2D/optimal dose(s)
Time frame: From baseline disease assessment until disease progression or initiation of a new anticancer therapy, assessed up to 15 months
ORR is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) in superficial and/or visceral lesions, assessed in separate tumor-specific expansion cohorts at the selected optimal dose(s)/RP2D(s), per protocol-defined response criteria
11 secondary outcomes
Objective Response Rate (ORR) in lesions (Phase 1)
Time frame: From first dose through end of treatment (up to 12 weeks) and follow-up tumor assessments, assessed up to 12 months
Systemic exposure (PK) of N17350 following intratumoral administration
Time frame: From first dose through 30 days after last dose, assessed up to 4 months.
Systemic exposure (PK) of N17350 following intratumoral administration
Time frame: From first dose through 30 days after last dose, assessed up to 4 months.
Systemic exposure (PK) of N17350 following intratumoral administration
Time frame: From first dose through 30 days after last dose, assessed up to 4 months.
Systemic exposure (PK) of N17350 following intratumoral administration
Time frame: From first dose through 30 days after last dose, assessed up to 4 months.
Systemic exposure (PK) of N17350 following intratumoral administration
Time frame: From first dose through 30 days after last dose, assessed up to 4 months.
Immunogenicity of N17350 (anti-drug antibodies [ADA])
Time frame: From first dose through 30 days after last dose, assessed up to 4 months
Preliminary antitumor activity in lesions (ORR, DOR, DCR, CBR)
Time frame: From first dose until disease progression or start of new anticancer therapy, assessed up to 15 months
Pharmacodynamic (PD) biomarkers
Time frame: From first dose through 30 days after last dose, assessed up to 4 months
Progression-Free Survival (PFS) (Phase 2)
Time frame: From first dose until disease progression or death, assessed up to 15 months
Overall Survival (OS) (Phase 2)
Time frame: From first dose until death, assessed up to 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Undecided. An IPD sharing plan has not yet been finalized. Any decision to share individual participant data will be determined after study completion and will consider participant privacy, informed consent, and applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Roberts-Thomson study director
Onchilles Pharma
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing N17350 in people with Neoplasms, Solid Tumor and Breast Neoplasms, Triple-Negative, run by Onchilles Pharma Inc at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Onchilles Pharma Clinical Trials (650-270-0891, clinicaltrials@onchillespharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Safety and tolerability of intratumoral N17350, including incidence of DLTs and adverse events (time frame: DLTs: First 28 days; TEAEs/SAEs/laboratory abnormalities: From enrollment through 30 days after last dose assessed up to 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.