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.
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.
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.
Sequential
A novel hGIIA-Vimentin Inhibitor
DrugPhase I, dose escalation includes 4 increasing doses, 10mg, 30mg, 60mg and 120mg.
Dose expansion
DrugPhase II will enrol participants in selected indication(s) and will be given one of the two recommended doses by the SMC.
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)
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)
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).
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)
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