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RECRUITING
NCT06926075
PHASE1/PHASE2

Early Phase Study of KESONOTIDE™in Participants With Solid Tumours

Sponsor: Filamon LTD

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-11-07

Completion Date

2027-10-26

Last Updated

2026-03-17

Healthy Volunteers

No

Interventions

DRUG

A novel hGIIA-Vimentin Inhibitor

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

DRUG

Dose 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