Actively Recruiting
Early Phase Study of KESONOTIDE™in Participants With Solid Tumours
Led by Filamon LTD · Updated on 2026-03-17
80
Participants Needed
3
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early Phase Study of KESONOTIDE™in Participants With Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults aged 18 years or older
- ECOG performance status score of 0 or 1
- Life expectancy greater than 12 weeks as judged by the investigator
- Measurable or evaluable disease by CT/MRI per RECIST v1.1, except prostate and breast cancer with bone-only metastases and glioma
- Histologically or cytologically confirmed locally advanced or metastatic solid cancers
- Adequate organ function within 7 days before starting treatment including platelet count >100 x 10^9/L, hemoglobin >9.0 g/dL, ANC >1.5 x 10^9/L, creatinine <1.5 times ULN, AST and ALT <3 times ULN (or <5 times ULN with liver metastases), total bilirubin ≤1.5 times ULN, serum albumin ≥2.5 g/dL, INR/PT and APTT ≤1.5 times ULN
- Participants of reproductive potential must agree to use adequate contraception during and 90 days after treatment
- Male participants must not freeze or donate sperm from screening until 90 days after last dose
- Female participants must not donate or retrieve ova from screening until 90 days after last dose
- Have failed or refused standard of care or next line therapy and can safely delay approved treatments
- Additional criteria for parts 2 and 3 include measurable disease or abnormal biomarkers and suitability for dose expansion
- Participants from phase I benefitting from treatment may be eligible for parts 2 and 3
You will not qualify if you...
- Unable to stop anti-inflammatory medications or statins before and during the study (topical steroids allowed)
- Received investigational products within 4 weeks or five half-lives before study start
- Previous adverse reactions unresolved above Grade 1 except alopecia and fatigue
- Active clinically significant infection
- Significant or recurrent fluid accumulation like ascites or pleural effusions
- History of myocardial infarction or unstable angina within 6 months
- History of symptomatic congestive heart failure (NYHA II-IV) or serious arrhythmia needing treatment
- Uncontrolled mental illness
- Expected non-compliance or unwillingness to adhere to study procedures
- Deemed inappropriate for the trial by investigator
- Additional exclusion for parts 2 and 3: more than 2 prior lines of therapy
AI-Screening
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Trial Site Locations
Total: 3 locations
1
St George Private Hospital
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
2
South Western Sydney Local Health District
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
3
Southside Cancer Centre
Miranda, New South Wales, Australia, 2228
Actively Recruiting
Research Team
A
Admir Huseincehajic
CONTACT
G
Graham Kelly
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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