Early Phase Study of Kesonotide in Participants With Solid Tumours

NCT ID: NCT06926075

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-07
• Study Completion Date: 2027-10-26

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase I, Single Arm, dose escalation

Group Type: EXPERIMENTAL

A novel hGIIA-Vimentin Inhibitor

Intervention Type: DRUG

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

Dose expansion

Intervention Type: DRUG

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

2 Arms of selected indication and recommended dose

Group Type: EXPERIMENTAL

A novel hGIIA-Vimentin Inhibitor

Intervention Type: DRUG

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

Dose expansion

Intervention Type: DRUG

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

Interventions

A novel hGIIA-Vimentin Inhibitor

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).
• Has an ECOG performance status score of 0 or 1.
• Has a life expectancy of > 12 weeks in the opinion of the investigator.
• Measurable or evaluable disease by CT/MRI according to RECIST v1.1, except for prostate and breast cancer (bone only metastases are acceptable) and glioma.
• Histologically or cytologically confirmed locally advanced/metastatic solid cancers.
• Has adequate organ function within 7 days prior to Day 1 of Cycle 1, defined as below:
• Laboratory Value
• Hematology
• Platelet count > 100 x 109/L
• Hb > 9.0 g/dL
• ANC > 1.5 x 109/L
• Renal Function
• Creatinine < 1.5 x ULN
• Hepatic Function
• AST and ALT < 3 x ULN for the reference laboratory or < 5 x ULN in the presence of liver metastases
• Total bilirubin ≤ 1.5 x ULN
• Serum albumin ≥ 2.5 g/dL
• INR/PT and APTT ≤ 1.5 x ULN
• Male and female participants of reproductive/childbearing potential must agree to use adequate contraceptive methods (e.g., double barrier or intrauterine contraceptive) for at least 90 days during the study and after the last dose of study drug.
• Male participants must not freeze or donate sperm starting at screening and throughout the study period, and at least 90 days after the final study drug administration.
• Female participants must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and at least 90 days after the final study drug administration.
• Has failed standard of care or refused next line therapy at the present time and if approved treatment options are still available, can delay approved treatments without harm as judged by the investigator (e.g., patients requesting a break between lines of therapy).

• Measurable disease (as defined for Part 1) or recognised and abnormal biomarker levels (e.g., PSA for prostate cancer, CA15.3 for breast cancer).
• Defined diseases or disease states of interest, suitable for dose expansion.
• Patients who have enrolled in Part 1 of the study (dose-escalation), and in the opinion of the investigator, are benefitting from treatment, may be eligible for Parts 2 and 3.

Exclusion Criteria

• Participants who are unable to cease any anti-inflammatory medications or statins prior to and during the study, including non-steroidal anti-inflammatories, oral steroids at any dose; topical steroids and anti-inflammatories are allowable.
• Participants who have participated in other clinical trials and received investigational products within 4 weeks, or within five half-lives of the treatment, whichever is longer, before Cycle 1 Day 1 of the study period.
• Previous adverse reactions which have not returned to Grade 0 or 1 according to NCI-CTCAE v5.0 (except alopecia and fatigue) at the screening visit.
• A clinically significant active infection determined by the investigator.
• Significant or recurrent third space accumulation (e.g., ascites or pleural effusions) according to the investigator.
• Has a medical history of myocardial infraction or unstable angina within 6 months before enrolment.
• Has a medical history of symptomatic CHF (New York Heart Association (NYHA) classes II-IV) or serious cardiac arrhythmia requiring treatment.
• Has a history or presence of uncontrolled mental illness.
• The participant is expected to be non-compliant with critical trial procedures and is not willing or able to adhere to the trial requirements during the study.
• Participants are deemed inappropriate for this clinical trial at the discretion of the investigator.

• Patients must not have more than 2 prior lines of therapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Filamon LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St George Private Hospital

Kogarah, New South Wales, Australia

Site Status: RECRUITING

South Western Sydney Local Health District

Liverpool, New South Wales, Australia

Site Status: RECRUITING

Southside Cancer Centre

Miranda, New South Wales, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Admir Huseincehajic

Role: CONTACT

admir.huseincehajic@filamon.com

+61467451064

Graham Kelly

Role: CONTACT

graham.kelly@filamon.com

+61 429 854 390

Facility Contacts

Tracy Liaw

Role: primary

liawt@ramsayhealth.com.au

+61295985022

Angela Giagodi

Role: primary

angelina.giagodi@health.nsw.gov.au

+61499793000

Elizabeth Heard

Role: primary

trials@cancercarefoundation.org.au

+61285569300

Other Identifiers

FLM-CT002

Identifier Type: -

Identifier Source: org_study_id