Early Phase Study of KESONOTIDE™in Participants With Solid Tumours
ADVICE
An Adaptive Phase I/II Study of KESONOTIDE™, a Novel hGIIA-vimentin Inhibitor, in Participants With Solid Tumours
1 other identifier
interventional
80
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2025
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2025
CompletedFirst Posted
Study publicly available on registry
April 13, 2025
CompletedStudy Start
First participant enrolled
November 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 26, 2027
March 17, 2026
March 1, 2026
2 years
March 20, 2025
March 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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)
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)
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).
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)
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
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
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.
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)
Cycle 1 (21 days)
Study Arms (2)
Phase I, Single Arm, dose escalation
EXPERIMENTAL2 Arms of selected indication and recommended dose
EXPERIMENTALInterventions
Phase I, dose escalation includes 4 increasing doses, 10mg, 30mg, 60mg and 120mg.
Phase II will enrol participants in selected indication(s) and will be given one of the two recommended doses by the SMC.
Eligibility Criteria
You may qualify if:
- 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
- +10 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Filamon LTDlead
Study Sites (3)
St George Private Hospital
Kogarah, New South Wales, 2217, Australia
South Western Sydney Local Health District
Liverpool, New South Wales, 2170, Australia
Southside Cancer Centre
Miranda, New South Wales, 2228, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2025
First Posted
April 13, 2025
Study Start
November 7, 2025
Primary Completion (Estimated)
October 26, 2027
Study Completion (Estimated)
October 26, 2027
Last Updated
March 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR