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Early Phase Study of KESONOTIDE™in Participants With Solid Tumours

NCT06926075 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Filamon LTD

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06926075 on ClinicalTrials.gov