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NOT YET RECRUITING
NCT07339176
PHASE1/PHASE2

Intratumoral N17350 in Advanced Solid Tumors

Sponsor: Onchilles Pharma Inc

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

275

Start Date

2026-03

Completion Date

2029-11

Last Updated

2026-01-14

Healthy Volunteers

No

Interventions

BIOLOGICAL

N17350

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

Locations (1)

Westmead Hospital

Westmead, New South Wales, Australia