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
Age ≥18 years (or legal age of consent in the study jurisdiction).
Able to provide written informed consent and willing/able to comply with study procedures, visits, and follow-up.
Advanced solid tumor malignancy (excluding lymphoma and other hematologic malignancies), with disease that has progressed on, is intolerant of, or is ineligible for standard therapies known to provide clinical benefit, or for whom no standard therapy is available.
ECOG performance status 0-1.
Serious psychiatric, medical, or other condition that would interfere with study participation or protocol procedures, in the investigator's judgment.
History of solid organ transplant.
Alpha-1 antitrypsin deficiency.
Hereditary or acquired bleeding disorder/coagulation factor deficiency.
Sequential
N17350
Biological/VaccineN17350 is a recombinant mutant porcine pancreatic elastase (PPE) developed to target the neutrophil elastase (ELANE) pathway.
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Treatment groupsSee each treatment group below.
Phase 1: Safety and tolerability of intratumoral N17350, including incidence of DLTs and adverse events
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)
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
Objective Response Rate (ORR) in lesions (Phase 1)
ORR is defined as the proportion of participants with a best overall response of CR or PR in superficial and visceral lesions, assessed during dose escalation and backfill cohorts per RECIST v1.1 and/or IT-RECIST, as applicable
Systemic exposure (PK) of N17350 following intratumoral administration
Systemic exposure to N17350 will be assessed by serum concentrations of active and inactive N17350
Systemic exposure (PK) of N17350 following intratumoral administration
Systemic exposure to N17350 will be assessed by serum concentrations of N17350, and derived PK parameter of Cmax
Systemic exposure (PK) of N17350 following intratumoral administration
Systemic exposure to N17350 will be assessed by serum concentrations of N17350, and derived PK parameter of Tmax
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Onchilles Pharma Inc
Lead sponsor
Onchilles Pharma Pty Ltd
Collaborator
