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.
This clinical trial is an adaptive phase I/II study of KESONOTIDE™, a novel hGIIA-vimentin inhibitor in participants with solid tumours. This is a multicentre, open-label Phase I/II clinical trial. Phase I part of the study is a classic 3+3 dose escalation to identify the Maximum Tolerated Dose, Recommended Phase 2 Dose and Optimal Biological Dose. In the Phase II study, participants will be given one of the two recommended dose levels. This may be as monotherapy or in combination with standard of care. The study treatment will be a 21-day treatment Cycle (once every 3 weeks) and KESONOTIDE™ will be orally administered. Study treatment will continue until disease progression, loss of clinical benefit, unacceptable toxicity, withdrawal of consent, lost to follow-up or another discontinuation criterion. This trial will utilise an adaptive design which permits treatment arm modification or early stopping for efficacy or futility.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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.
St George Private Hospital
Kogarah, New South Wales, Australia
RECRUITINGSouth Western Sydney Local Health District
Liverpool, New South Wales, Australia
RECRUITINGSouthside Cancer Centre
Miranda, New South Wales, Australia
RECRUITINGTo 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)
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: Cycle 1 (21 days)
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