drugset / Trial / NCT06926075

Early Phase Study of KESONOTIDE™in Participants With Solid Tumours

NCT06926075 ↗

Phase 1/2 Recruiting 80 enrolled Filamon LTD
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2025-11-07
Primary completion
2027-10-26
Completion
2027-10-26

Drugs

EvaluationDrugModalityDoseRoute
Subject KESONOTIDE Unknown 10 mg Oral
Subject KESONOTIDE Unknown 30 mg Oral
Subject KESONOTIDE Unknown 60 mg Oral
Subject KESONOTIDE Unknown 120 mg Oral