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Intratumoral N17350 in Advanced Solid Tumors

NCT07339176 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2026-05-14

No results posted yet for this study

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. 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

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

Interventions

BIOLOGICAL

N17350

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

Sponsors & Collaborators

  • Onchilles Pharma Pty Ltd

    collaborator UNKNOWN

  • Onchilles Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Lev Becker · Onchilles Pharma

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-07-31
Completion
2029-11-30
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07339176 on ClinicalTrials.gov