Prostate CancersPhase 1/2ADVICENCT06926075
Early Phase Study of KESONOTIDE™in Participants With Solid Tumours
A Phase 1/2 study testing A novel hGIIA-Vimentin Inhibitor and Dose expansion in people with Prostate Cancers and Breast Cancer, run by Filamon LTD at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancers, Breast Cancer, Lung Cancers
- What is being tested?
- A novel hGIIA-Vimentin Inhibitor and Dose expansion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesAustralia
- Study dates
- 7 Nov 2025to 26 Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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).
- Additional Inclusion Criteria for Parts 2 and 3:
- 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.
Who cannot join
- 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.
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- 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.
- Additional Exclusion Criteria for Parts 2 and 3:
- Patients must not have more than 2 prior lines of therapy.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Recruiting
St George Private Hospital
Kogarah, New South Wales, 2217
Tracy Liaw, +61295985022, liawt@ramsayhealth.com.au
Kate Wilkinson
- Recruiting
South Western Sydney Local Health District
Liverpool, New South Wales, 2170
Angela Giagodi, +61499793000, angelina.giagodi@health.nsw.gov.au
Adam Cooper
- Recruiting
Southside Cancer Centre
Miranda, New South Wales, 2228
Elizabeth Heard, +61285569300, trials@cancercarefoundation.org.au
Mahmood Alam, Doctor
About this study
Official title: An Adaptive Phase I/II Study of KESONOTIDE™, a Novel hGIIA-vimentin Inhibitor, in Participants With Solid Tumours
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.
Read the 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
- Being tested
- A novel hGIIA-Vimentin Inhibitor, Dose expansion
- Keywords
- kesonotide, vimentin inhibotor
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Glioblastoma, Pancreatic Neoplasms, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A novel hGIIA-Vimentin InhibitorDrug
Phase I, dose escalation includes 4 increasing doses, 10mg, 30mg, 60mg and 120mg.
Dose expansionDrug
Phase II will enrol participants in selected indication(s) and will be given one of the two recommended doses by the SMC.
| Study group | Role | What they receive |
|---|---|---|
| Phase I, Single Arm, dose escalation | Experimental | Not described Receives: Drug: A novel hGIIA-Vimentin Inhibitor; Drug: Dose expansion |
| 2 Arms of selected indication and recommended dose | Experimental | Not described Receives: Drug: A novel hGIIA-Vimentin Inhibitor; Drug: Dose expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability (Incidence of SAEs) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Incidence of serious adverse events (SAEs)
Measured: Cycle 1 (21 days)
To evaluate the safety and tolerability (Treatment emergent adverse effects) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Treatment emergent adverse effects (TEAEs)
Measured: Cycle 1 (21 days)
To evaluate the safety and tolerability (Incidence and nature of DLTs) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Incidence and nature of dose-limiting toxicities (DLTs).
Measured: Cycle 1 (21 days)
To evaluate the safety and tolerability (Changes in vital signs/Heart Rate bpm) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Changes in vital sign measurements (Hear rate in beats per minute)
Measured: Cycle 1 (21 days)
To evaluate the safety and tolerability (Clinical safety laboratory parameters) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Clinical safety laboratory parameters (abnormal haematology, clinical chemistry and coagulation blood tests; pregnancy test, as per CTCAE v5.0 classification
Measured: Cycle 1 (21 days)
To evaluate the safety and tolerability (ECG parameters) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Electrocardiogram (ECG) parameters (Heart Rate, PR Interval, P wave, QRS Complex, T wave, ST Segment, QT Interval) where combined parameters make up a full ECG tracing results
Measured: Cycle 1 (21 days)
To evaluate the safety and tolerability (ECOG performance status) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Eastern Cooperative Oncology Group (ECOG) performance status findings.
Measured: Cycle 1 (21 days)
To evaluate the safety and tolerability (Changes in vital signs/Blood Pressure) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Changes in vital sign measurements (blood pressure in systolic and diastolic mm Hg)
Measured: Cycle 1 (21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start7 Nov 2025
- Primary completion26 Oct 2027 (estimated)
- Study completion26 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Filamon LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926075
- Sponsor's protocol ID
- FLM-CT002
- Acronym
- ADVICE
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Phase I/II Study of KESONOTIDE™, a Novel hGIIA-vimentin Inhibitor, in Participants With Solid Tumours
- ClinicalTrials.gov ID
- NCT06926075
- Acronym / sponsor ID
- ADVICE / FLM-CT002
- Conditions
- Prostate Cancers, Breast Cancer, Lung Cancers, Ovarian Cancer, Glioblastoma Multiforme (GBM), Pancreas Cancer
- Keywords
- kesonotide, vimentin inhibotor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Filamon LTDIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 26 Oct 2027 (estimated)
- Study completion
- 26 Oct 2027 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dose escalation
| Arm | Type | Receives |
|---|---|---|
| Phase I, Single Arm, dose escalation | Experimental | Drug: A novel hGIIA-Vimentin Inhibitor, Drug: Dose expansion |
| 2 Arms of selected indication and recommended dose | Experimental | Drug: A novel hGIIA-Vimentin Inhibitor, Drug: Dose expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A novel hGIIA-Vimentin InhibitorPhase I, dose escalation includes 4 increasing doses, 10mg, 30mg, 60mg and 120mg. | Drug | 2 Arms of selected indication and recommended dose, Phase I, Single Arm, dose escalation |
| Dose expansionPhase II will enrol participants in selected indication(s) and will be given one of the two recommended doses by the SMC. | Drug | 2 Arms of selected indication and recommended dose, Phase I, Single Arm, dose escalation |
Primary outcome
To evaluate the safety and tolerability (Incidence of SAEs) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Time frame: Cycle 1 (21 days)
Incidence of serious adverse events (SAEs)
To evaluate the safety and tolerability (Treatment emergent adverse effects) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Time frame: Cycle 1 (21 days)
Treatment emergent adverse effects (TEAEs)
To evaluate the safety and tolerability (Incidence and nature of DLTs) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Time frame: Cycle 1 (21 days)
Incidence and nature of dose-limiting toxicities (DLTs).
To evaluate the safety and tolerability (Changes in vital signs/Heart Rate bpm) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Time frame: Cycle 1 (21 days)
Changes in vital sign measurements (Hear rate in beats per minute)
To evaluate the safety and tolerability (Clinical safety laboratory parameters) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Time frame: Cycle 1 (21 days)
Clinical safety laboratory parameters (abnormal haematology, clinical chemistry and coagulation blood tests; pregnancy test, as per CTCAE v5.0 classification
To evaluate the safety and tolerability (ECG parameters) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Time frame: Cycle 1 (21 days)
Electrocardiogram (ECG) parameters (Heart Rate, PR Interval, P wave, QRS Complex, T wave, ST Segment, QT Interval) where combined parameters make up a full ECG tracing results
To evaluate the safety and tolerability (ECOG performance status) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Time frame: Cycle 1 (21 days)
Eastern Cooperative Oncology Group (ECOG) performance status findings.
To evaluate the safety and tolerability (Changes in vital signs/Blood Pressure) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Time frame: Cycle 1 (21 days)
Changes in vital sign measurements (blood pressure in systolic and diastolic mm Hg)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing A novel hGIIA-Vimentin Inhibitor and Dose expansion in people with Prostate Cancers and Breast Cancer, run by Filamon LTD at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Admir Huseincehajic (+61467451064, admir.huseincehajic@filamon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability (Incidence of SAEs) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers. (time frame: Cycle 1 (21 days)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.