Early Phase Study of KESONOTIDE™in Participants With Solid Tumours (NCT06926075) | Clinical Trial Compass
RecruitingPhase 1/2
Early Phase Study of KESONOTIDE™in Participants With Solid Tumours
Australia80 participantsStarted 2025-11-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the safety and tolerability (Incidence of SAEs) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Timeframe: Cycle 1 (21 days)
2
To evaluate the safety and tolerability (Treatment emergent adverse effects) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Timeframe: Cycle 1 (21 days)
3
To evaluate the safety and tolerability (Incidence and nature of DLTs) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Timeframe: Cycle 1 (21 days)
4
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.
Timeframe: Cycle 1 (21 days)
5
To evaluate the safety and tolerability (Clinical safety laboratory parameters) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Timeframe: Cycle 1 (21 days)
6
To evaluate the safety and tolerability (ECG parameters) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
To evaluate the safety and tolerability (ECOG performance status) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.
Timeframe: Cycle 1 (21 days)
8
To evaluate the safety and tolerability (Changes in vital signs/Blood Pressure) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers.