RecruitingPhase 1Phase 2NCT06926075

Early Phase Study of KESONOTIDE™in Participants With Solid Tumours

An Adaptive Phase I/II Study of KESONOTIDE™, a Novel hGIIA-vimentin Inhibitor, in Participants With Solid Tumours


Sponsor

Filamon LTD

Enrollment

80 participants

Start Date

Nov 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial is an adaptive study of a novel vimentin inhibitor in cancers. It is an open label, multicentre, single ascending dose level in phase I and cohort exploration in phase II. Primary objective is to evaluate safety and tolerability of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers. Secondary objective is to characterise the pharmacokinetics of KESONOTIDE™. Phase I study will enrol 20-32 participants and Phase II approximately 80 participants.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing KESONOTIDE — a new experimental drug — for safety and to find the right dose in patients with advanced or metastatic solid tumours (any cancer that forms a lump) that has not responded to standard treatments. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of an advanced or metastatic solid cancer - Your general health is good (ECOG 0 or 1) and your expected survival is more than 12 weeks - Your tumour can be measured on scans, or you have evaluable disease - Your blood counts, kidney, and liver function meet acceptable levels **You may NOT be eligible if...** - Your cancer has spread to the brain and is active/unstable - You have had prior serious allergic reactions to similar drugs - You are pregnant or breastfeeding - Your organ function is too impaired for the treatment Talk to your doctor to see if this trial is right for you.

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

DRUGA novel hGIIA-Vimentin Inhibitor

Phase I, dose escalation includes 4 increasing doses, 10mg, 30mg, 60mg and 120mg.

DRUGDose expansion

Phase II will enrol participants in selected indication(s) and will be given one of the two recommended doses by the SMC.


Locations(3)

St George Private Hospital

Kogarah, New South Wales, Australia

South Western Sydney Local Health District

Liverpool, New South Wales, Australia

Southside Cancer Centre

Miranda, New South Wales, Australia

View Full Details on ClinicalTrials.gov

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NCT06926075


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