RecruitingPhase 1Phase 2NCT07339176

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


Sponsor

Onchilles Pharma Inc

Enrollment

275 participants

Start Date

May 25, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called N17350 for people with breast neoplasms, triple-negative, carcinoma, non-small cell lung, and other related conditions. The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALN17350

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


Locations(6)

The Angeles Clinic and Research Institute

Los Angeles, California, United States

UCLA - Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Calvary Mater Hospital

Newcastle, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

View Full Details on ClinicalTrials.gov

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NCT07339176


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