Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

Early Phase Study of KESONOTIDE™in Participants With Solid Tumours (NCT06926075) is a Phase 1 / Phase 2 interventional studying Prostate Cancers and Breast Cancer, sponsored by Filamon LTD. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Prostate Cancers, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 80 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Prostate Cancers subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of willing to sign a consent form). - 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. - diagnosed by tissue sample (biopsy-confirmed) locally advanced/metastatic solid cancers. - Has your organs (liver, kidneys, etc.) are working well enough based on blood tests 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). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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). 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. 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. Additional Exclusion Criteria for Parts 2 and 3: \- Patients must not have more than 2 prior lines of therapy.

Treatments Being Tested

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.

Locations (3)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

St George Private Hospital
Kogarah, New South Wales, Australia
South Western Sydney Local Health District
Liverpool, New South Wales, Australia
Southside Cancer Centre
Miranda, New South Wales, Australia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06926075), the sponsor (Filamon LTD), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06926075 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06926075?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06926075?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06926075. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06926075. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.