Intratumoral N17350 in Advanced Solid Tumors

NCT07339176 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: OP-NEU-101
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does N17350 cause tumors to shrink or stop growing in some participants with advanced solid tumors?
2. 2.Are there any side effects for participants when taking N17350?
3. 3.What is the safest dose of N17350 and the dose that should be used for further study?
4. 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.
5. 5.Receive injections of N17350 into tumor lesions every second week for 8 or 12 weeks
6. 6.Visit the clinic regularly for checkups, blood tests, and monitoring for side effects
7. 7.Have imaging scans (such as CT or MRI) to measure tumors and assess response
8. 8.Provide blood samples and, when required, tumor samples to help researchers understand how N17350 affects the tumor and the immune system

Conditions

Neoplasms, Solid Tumor; Breast Neoplasms, Triple-Negative; Squamous Cell Carcinoma of Skin; Melanoma; Head and Neck Neoplasms; Carcinoma, Squamous Cell; Carcinoma, Non-Small-Cell Lung

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; ELANE; Phase 2; ELANE pathway; TNBC; cuSCC; HNSCC; SCCHN; metastatic; elastase; therapeutic elastase; neutrophil elastase; New cancer therapy

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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)

  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

  From first dose through 30 days after last dose, assessed up to 4 months.

• Systemic exposure (PK) of N17350 following intratumoral administration

  From first dose through 30 days after last dose, assessed up to 4 months.

• Systemic exposure (PK) of N17350 following intratumoral administration

  From first dose through 30 days after last dose, assessed up to 4 months.

• Systemic exposure (PK) of N17350 following intratumoral administration

  From first dose through 30 days after last dose, assessed up to 4 months.

Study Arms (10)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Biological: N17350

Interventions

N17350 BIOLOGICAL

N17350 is a recombinant mutant porcine pancreatic elastase (PPE) developed to target the neutrophil elastase (ELANE) pathway.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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).
• 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:

Sponsors & Collaborators

• Onchilles Pharma Inc: lead
• Onchilles Pharma Pty Ltd: collaborator

Study Sites (1)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lev Becker

  Onchilles Pharma

  STUDY DIRECTOR

Central Study Contacts

Onchilles Pharma Clinical Trials

CONTACT

650-270-0891; clinicaltrials@onchillespharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 14, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): November 1, 2029
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

AU (1)