RecruitingPhase 1 / Phase 2

Intratumoral N17350 in Advanced Solid Tumors

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections, Blood draws, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Researchers will give N17350 directly into tumor lesions using a needle (intratumoral injection)."
  • "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"
  • "N17350 will be administered by injection directly into tumor lesions (intratumoral injection)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests N17350 in adults with advanced solid tumors when standard treatments do not work, cannot be used, or are not available. Researchers will check whether it shrinks tumors or stops their growth, learn about side effects, and find the best dose. Everyone will get N17350 through a needle directly into a tumor every other week for 8 or 12 weeks; no one gets a placebo.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18, or the legal age to consent where the study takes place. Give written consent and be able to follow study visits and procedures.
  • Have an advanced solid tumor, not lymphoma or another blood cancer. Standard treatments must have failed, caused problems you could not tolerate, or not be an option.
  • Be fully active or able to do light work, even if hard physical activity is limited.
  • Have tumors that can be measured and safely injected, within the study's size limits. Part A3 requires a measurable tumor and a separate tumor that can be injected.
  • Have recovered from most side effects of past cancer treatment to mild levels or your usual health level. Some exceptions are allowed.
  • Have good enough liver, kidney, blood-clotting, and blood-cell test results. Have no blood transfusions in the 7 days before joining.
  • Be willing to give tumor samples before and during treatment when safe, and/or have stored tumor tissue from the past 2 years, as the study requires.
  • If able to have children, use effective birth control and avoid pregnancy or fathering a child through 30 days after the last dose. Those who can become pregnant need a negative pregnancy test within 14 days before treatment.

Who can't join

  • Have a serious health or mental health condition that would prevent taking part, a past organ transplant, a bleeding disorder, or alpha-1 antitrypsin deficiency—a lack of a protein that protects the lungs.
  • Be pregnant or breastfeeding, or have a known allergy to N17350 or its ingredients.
  • Have an autoimmune disease, where the immune system attacks the body, that needed whole-body treatment in the past 6 months. Certain serious immune side effects from past immunotherapy also rule out joining.
  • Have a heart test showing a QTcF over 480 milliseconds, meaning the heart takes too long to reset between beats.
  • Have another active cancer now or within the past 2 years, with some low-risk exceptions. Unstable cancer in the brain or cancer in the lining around the brain and spinal cord also rules out joining.
  • Have had cancer drugs or radiation too recently, or still have more than mild side effects from past treatment. The waiting time depends on the treatment, and some side effects are allowed.
  • Have an active infection needing whole-body treatment within 14 days before the first dose. Hepatitis B, hepatitis C, and HIV must meet the study's treatment and test-result rules.
  • Have used blood thinners within 14 days before the first dose, or certain whole-body medicines that weaken the immune system or reduce swelling within 4 weeks. Ongoing steroid doses above the equivalent of 10 mg of prednisone daily are not allowed; some other steroid uses are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Age ≥18 years (or legal age of consent in the study jurisdiction). 2. Able to provide written informed consent and willing/able to comply with study procedures, visits, and follow-up. 3. 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. 4. ECOG performance status 0-1. 5. Measurable disease per IT-RECIST (Parts A1/A2) and RECIST v1.1 (Part A3), as applicable. 6. At least one injectable tumor lesion, meeting superficial or visceral criteria and deemed safe/accessible for injection: 1. 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). 2. Visceral lesions: ≥10 mm and ≤50 mm in longest diameter, accessible for direct injection. 3. 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). 4. Expansion (Part A3): at least 1 measurable lesion and at least 1 additional injectable lesion suitable for injection. 7. 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). 8. Adequate organ function, including hepatic, renal, and coagulation parameters per protocol-defined thresholds. 9. Adequate bone marrow function without transfusion support within 7 days prior to enrollment, per protocol-defined thresholds. 10. 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. 11. 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. Exclusion Criteria: 1. Serious psychiatric, medical, or other condition that would interfere with study participation or protocol procedures, in the investigator's judgment. 2. History of solid organ transplant. 3. Alpha-1 antitrypsin deficiency. 4. Hereditary or acquired bleeding disorder/coagulation factor deficiency. 5. Active autoimmune disease requiring systemic treatment within the past 6 months, except clinically stable autoimmune conditions in remission not requiring systemic therapy (per protocol). 6. Baseline QTcF \>480 ms. 7. Pregnant or breastfeeding. 8. 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). 9. 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). 10. 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. 11. Recent radiotherapy within 2 weeks prior to first dose. 12. Unresolved toxicity from prior anticancer therapy to \>Grade 1 or not at baseline (except Grade ≤2 neuropathy and other allowed exceptions per protocol). 13. 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). 14. Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose. 15. Chronic viral infections not meeting protocol criteria: 1. HBV with detectable DNA unless on appropriate antiviral therapy 2. Active HCV with detectable HCV RNA (treated HCV permitted if RNA undetectable) 3. HIV infection with CD4+ count \<300/μL, detectable viral load, or HIV-related illness within 6 months 16. Use of systemic anticoagulants (e.g., warfarin, LMWH, DOACs) within 14 days prior to first dose. 17. 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. 18. Known allergy/hypersensitivity to N17350 or any excipients.

Study sites (6)

CA

NY

TX