Trials / Recruiting
RecruitingNCT06926075
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Filamon LTD · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This clinical trial is an adaptive phase I/II study of KESONOTIDE™, a novel hGIIA-vimentin inhibitor in participants with solid tumours. This is a multicentre, open-label Phase I/II clinical trial. Phase I part of the study is a classic 3+3 dose escalation to identify the Maximum Tolerated Dose, Recommended Phase 2 Dose and Optimal Biological Dose. In the Phase II study, participants will be given one of the two recommended dose levels. This may be as monotherapy or in combination with standard of care. The study treatment will be a 21-day treatment Cycle (once every 3 weeks) and KESONOTIDE™ will be orally administered. Study treatment will continue until disease progression, loss of clinical benefit, unacceptable toxicity, withdrawal of consent, lost to follow-up or another discontinuation criterion. This trial will utilise an adaptive design which permits treatment arm modification or early stopping for efficacy or futility.
Conditions
- Prostate Cancers
- Breast Cancer
- Lung Cancers
- Ovarian Cancer
- Glioblastoma Multiforme (GBM)
- Pancreas Cancer
- Skin Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-11-07
- Primary completion
- 2027-10-26
- Completion
- 2027-10-26
- First posted
- 2025-04-13
- Last updated
- 2026-03-17
Locations
3 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT06926075. Inclusion in this directory is not an endorsement.