Malignant Solid Tumour Clinical Trial
Official title:
A Phase I Multiple Ascending Dose Study of ASLAN002 (BMS 777607) in Subjects With Advanced or Metastatic Solid Tumours
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
;
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