Early‑phase KESONOTIDE™ treatment for solid tumors

An Adaptive Phase I/II Study of KESONOTIDE™, a Novel hGIIA-vimentin Inhibitor, in Participants With Solid Tumours

This trial tests an oral drug called KESONOTIDE™ (a vimentin inhibitor) to see if it is safe and tolerable in adults with advanced or metastatic solid tumors like prostate, breast, lung, ovarian cancer, or glioblastoma.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Filamon LTD (Industry-sponsored)
• Locations: 3 sites (Kogarah, New South Wales and 2 other locations)
• Trial ID: NCT06926075 on ClinicalTrials.gov

What this trial studies

This is an open‑label, multicentre adaptive Phase I/II study of KESONOTIDE™, an oral hGIIA–vimentin inhibitor, in adults with advanced or metastatic solid tumors. Phase I uses a classic 3+3 single ascending‑dose design to identify the maximum tolerated dose, recommended Phase II dose, and optimal biological dose, enrolling about 20–32 participants. Phase II will explore cohorts treated at one of two recommended dose levels given every 21 days as monotherapy or possibly in combination with standard of care, with roughly 80 participants planned. Safety, tolerability, and pharmacokinetics are key objectives and the adaptive design permits arm modification or early stopping for efficacy or futility.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed advanced or metastatic solid tumors such as prostate, breast, lung, ovarian cancer, or glioblastoma who have ECOG 0–1, life expectancy >12 weeks, measurable or evaluable disease, and adequate organ function are ideal candidates.

Not a fit: Patients with poor performance status (ECOG ≥2), inadequate organ function or bloodwork outside the entry limits, or those unable to attend the Australian sites are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, KESONOTIDE™ could provide a new targeted oral therapy that slows tumor growth in vimentin‑expressing solid cancers.

How similar studies have performed: Targeting vimentin is a relatively novel approach with mainly preclinical support and limited prior clinical evidence of efficacy in solid tumors.

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).

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.

Where this trial is running

Kogarah, New South Wales and 2 other locations

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

Study contacts

• Study coordinator: Admir Huseincehajic

Conditions Prostate Cancers; Breast Cancer; Lung Cancers; Ovarian Cancer; Glioblastoma Multiforme; Pancreas Cancer; Skin Cancer; kesonotide, vimentin inhibotor