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An Adaptive Phase I/II Study of KESONOTIDE12, a Novel hGIIA-vimentin Inhibitor, in Participants With Solid Tumours
Led by Filamon LTD · Updated on 2026-03-17
80
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating KESONOTIDE12, a new drug that inhibits the hGIIA-vimentin protein, in adults with advanced or metastatic solid tumors including prostate, breast, lung, ovarian, glioblastoma, pancreas, and skin cancers. This adaptive phase I/II trial aims primarily to assess the safety and tolerability of KESONOTIDE12 when given alone. The study also looks at how the drug moves through the body. The trial is open-label and multicenter, enrolling about 20-32 participants in phase I and around 80 in phase II. In phase I, participants receive escalating single doses of KESONOTIDE12 orally at 10mg, 30mg, 60mg, or 120mg to find the best dose with acceptable side effects. Phase II will give participants one of two recommended doses identified earlier, either alone or combined with standard treatments. Treatments are given in 21-day cycles and continue until the cancer worsens, side effects become unacceptable, or other reasons for stopping occur. The adaptive design allows for modifying treatment groups or stopping early based on effectiveness or safety. Participants will be closely monitored with regular assessments including physical exams, vital signs, heart rate, blood pressure, ECGs, laboratory tests, and performance status evaluations. Safety is carefully evaluated in the first 21-day cycle for serious adverse events and dose-limiting toxicities. The study tracks participants until disease progression, withdrawal, or loss to follow-up. The trial runs until October 2027, aiming to provide detailed safety and dosing information for KESONOTIDE12 in solid tumors.
CONDITIONS
Brief 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 according to RECIST v1.1, except for prostate and breast cancer (bone only metastases accepted) and glioma
- Histologically or cytologically confirmed locally advanced or metastatic solid cancers
- Adequate organ function within 7 days before starting treatment, including platelet count above 100 x 10^9/L, hemoglobin above 9.0 g/dL, ANC above 1.5 x 10^9/L, creatinine less than 1.5 x ULN, liver enzymes less than 3 x ULN (or 5 x ULN with liver metastases), total bilirubin 1.5 x ULN or less, serum albumin 2.5 g/dL or more, and INR/PT and APTT 1.5 x ULN or less
- Agreement to use adequate contraceptive methods during and for 90 days after the study for participants of reproductive potential
- Male participants must not freeze or donate sperm during and for 90 days after treatment
- Female participants must not donate or retrieve ova for personal use during and for 90 days after treatment
- Have failed standard care or refused next line therapy and can safely delay approved treatments if available
- Additional criteria for parts 2 and 3 include measurable disease or abnormal biomarkers and suitability for dose expansion
You will not qualify if you...
- Unable to stop anti-inflammatory medications or statins before and during the study (excluding topical steroids)
- Participation in other clinical trials with investigational products within 4 weeks or five half-lives before starting this study
- Previous adverse reactions not resolved to Grade 0 or 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 before enrollment
- History of symptomatic congestive heart failure (NYHA class II-IV) or serious cardiac arrhythmia needing treatment
- History or presence of uncontrolled mental illness
- Expected inability or unwillingness to comply with trial procedures
- Investigator judgment deeming participant inappropriate for the trial
- For parts 2 and 3, patients must not have more than 2 prior lines of therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants will receive KESONOTIDE™, a novel hGIIA-vimentin inhibitor, orally once every 3 weeks in 21-day treatment cycles. Treatment continues until disease progression, unacceptable toxicity, withdrawal, or other discontinuation reasons.
Visits every 3 weeks corresponding to each treatment cycle
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
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3
Southside Cancer Centre
Miranda, New South Wales, Australia, 2228
Actively Recruiting
Research Team
A
Admir Huseincehajic
G
Graham Kelly
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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