Early Phase Study of KESONOTIDE™in Participants With Solid Tumours
Trial Parameters
Brief 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.
Eligibility Criteria
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