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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 21, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07339176). This is a study registration, not published results. Lead sponsor: Onchilles Pharma Inc. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 275 participants (ESTIMATED). 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. Primary outcome measures: Phase 1: Safety and tolerability of intratumoral N17350, including incidence of DLTs and adverse events , DLTs: First 28 days; TEAEs/SAEs/laboratory abnormalities: From enrollment through 30 days after last dose assessed up to 4 months; Phase 2: Objective Response Rate (ORR) of lesions at RP2D/optimal dose(s) , From baseline disease assessment until disease progression or initiation of a new anticancer therapy, assessed up to 15 months. Brief 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