Neoplasms, Solid Tumor study: N17350
Official title Intratumoral N17350 in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07339176
What this study is testing
What is N17350?
an investigational injectable medicine being studied as a potential treatment for advanced solid tumors is designed to target the neutrophil elastase (ELANE) pathway
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if N17350 can shrink or stop growth of advanced solid tumors and to learn its safety and best dose.
- Who it's for
- Adults who have advanced solid tumors such as breast, skin, melanoma, head‑neck, lung or other cancers.
- What's involved
- Participants receive N17350 injected into their tumor every two weeks for 8 or 12 weeks, have regular clinic visits, blood tests, imaging scans and may give tumor samples.
- Time commitment
- The trial lasts up to 12 weeks with clinic visits every two weeks for injections and monitoring.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- ECOG performance status 0-1.
- Measurable disease per IT-RECIST (Parts A1/A2) and RECIST v1.1 (Part A3), as applicable.
You likely can't join 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...
- Baseline QTcF \>480 ms.
See the full eligibility 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...
- ECOG performance status 0-1.
- Measurable disease per IT-RECIST (Parts A1/A2) and RECIST v1.1 (Part A3), as applicable.
- 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...
- 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...
- Contraception requirements: participants of reproductive potential agree to use effective contraception and avoid pregnancy/fathering children from screening through 30 days after last dose
- 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...
- 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...
- 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.
- 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...
- Known allergy/hypersensitivity to N17350 or any excipients.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- San Diego, California, United States
- Buffalo, New York, United States
- Houston, Texas, United States
- Newcastle, New South Wales, Australia
- Westmead, New South Wales, Australia
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; San Diego, California, United States; Buffalo, New York, United States; Houston, Texas, United States; Newcastle, New South Wales, Australia; Westmead, New South Wales, Australia and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.