N17350 for Advanced Solid Tumors
This study is testing N17350, an investigational medicine, in adults with advanced solid tumors that have progressed or for which standard treatments are no longer working. N17350 is given directly into the tumor using a needle (intratumoral injection). The main goals are to see if N17350 can shrink or stop tumors from growing, to understand its safety and any side effects, and to find the best dose for future studies. This is an open-label study, meaning all participants will receive N17350, and both you and the study team will know you are receiving the treatment. The study aims to enroll 275 participants.
- Study design
- This is a Phase 1/2, open-label, interventional study. All 275 participants will receive N17350, and there is no placebo group.
- What's involved
- Participants will receive N17350 directly into tumor lesions. Safety will be assessed for up to 4 months, and tumor response will be assessed for up to 15 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be monitored for 30 days after the last dose, assessed up to 4 months. Tumor response will be assessed from baseline until disease progression or new anticancer therapy, assessed up to 15 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Intratumoral N17350 in Advanced Solid Tumors
At a glance
Conditions
NCT07339176
Where you'd take part
This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Calvary Mater Hospital
Newcastle, New South Wales, Australiastudy coordinator listed
Recruiting
Peter MacCallum Cancer Centre (PMCC)
Melbourne, Victoria, Australiastudy coordinator listed
Not yet recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New Yorkstudy coordinator listed
Recruiting
The Angeles Clinic and Research Institute
Los Angeles, Californiastudy coordinator listed
Not yet recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texasstudy coordinator listed
Not yet recruiting
UCLA - Jonsson Comprehensive Cancer Center
Los Angeles, Californiastudy coordinator listed
Not yet recruiting
University of California, San Francisco
San Francisco, Californiastudy coordinator listed
Not yet recruiting
Westmead Hospital
Westmead, New South Wales, Australiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Emily Roberts-Thomson · STUDY_DIRECTOR · Onchilles Pharma
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Phase 1: Safety and tolerability of intratumoral N17350, including incidence of DLTs and adverse eventsDLTs: First 28 days; TEAEs/SAEs/laboratory abnormalities: From enrollment through 30 days after last dose assessed up to 4 months
Safety and tolerability will be assessed by the incidence and severity of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), and by laboratory abnormalities graded per CTCAE
- 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
ORR is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) in superficial and/or visceral lesions, assessed in separate tumor-specific expansion cohorts at the selected optimal dose(s)/RP2D(s), per protocol-defined response criteria