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 KESONOTIDEā¢. Phase I study will enrol 20-32 participants and Phase II approximately 80 participants.
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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)
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)
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)
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)
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)
To evaluate the safety and tolerability (ECG parameters) of KESONOTIDE⢠as a monotherapy in participants with advanced/metastatic solid cancers.
Timeframe: 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.
Timeframe: 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.
Timeframe: Cycle 1 (21 days)