open label dose escalation study of ASLAN002 administered orally on a once daily schedule to subjects with advanced or metastatic solid tumours, who have either progressed on standard therapy or for whom standard therapy is not known

ASLAN002( BMS 777607)

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There is a great need for new therapies for carcinomas that have progressed on or not responded to current therapy. There are no approved Met targeted agents in standard clinical use. In the population of subjects with advanced carcinomas that are unresponsive to standard of care, and based on the relatively safe, reversible and monitorable toxicity profile of ASLAN002 in non clinical studies, the potential for benefit from ASLAN002 outweighs the potential risks for toxicity.

The purpose of this study is to identify the maximum tolerated dose of ASLAN002 in subjects with advanced or metastatic solid tumours, as well as to define the overall safety profile of ASLAN002.

The purpose of the study is

* To identify the maximum tolerated dose (MTD) of ASLAN002 in subjects with advanced or metastatic solid tumours
* To define the overall safety profile of ASLAN002
* To assess the effects of ASLAN002 on overall cardiac function as measured by blood pressure (BP), heart rate (HR), electrocardiogram (ECG) changes, and left ventricular function

Secondary:

* To characterize the pharmacokinetics (PK) of ASLAN002 and its N-oxide metabolite, following single and multiple dosing
* To provide a preliminary assessment of anti-tumour activity, as assessed by the Overall Response Rate (ORR) and changes from baseline in tumour size

A Phase I Multiple Ascending Dose Study of ASLAN002 in Subjects With Advanced or Metastatic Solid Tumours

A Phase I Multiple Ascending Dose Study of ASLAN002 (BMS 777607) in Subjects With Advanced or Metastatic Solid Tumours

MTD is defined as highest dose at which less than 1/3 of the treated subjects experience a DLT (Adverse events, vital signs, electrocardiogram (ECG), echocardiogram scans, serum chemistry, haematology, coagulation factors, urinalysis, ophthalmic examination, and physical examination would be monitored)

After the single dose of ASLAN002 (BMS 777607), the following PK parameters will be derived: maximum observed concentration (Cmax), time of maximum observed plasma concentration (Tmax), plasma half life (T-half), area under the concentration time curve from time zero extrapolated to infinity (AUC\[INF\]), the area under concentration time curve from time zero to 24 hours (AUC\[24\]), percent urinary recovery (%UR), renal clearance (CLR)

Anti-tumour activity as assessed by the ORR based on Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1, and the percentage change from baseline in the sum of longest diameters in target lesions at the first follow-up assessment

Spots Global Cancer Trial Database for aslan002( bms 777607)