This Phase Ia study aims to establish the maximum tolerated dose of once-weekly IV infused PG545 and to evaluate its safety in subjects with advanced solid tumours. In addition, the study will explore whether PG545 exposure results in changes to chemicals produced by the body that are associated with cancer growth and spread.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
PG545 will be administered once weekly, as a one hour IV infusion. Patients will be treated until they exhibit disease progression, withdraw due to poor tolerability, or the study reaches its defined end-point. This study is a dose escalation study with doses of 25 mg to 250 mg anticipated.
Nucleus Network Ltd
Melbourne, Victoria, Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia
Determination of maximum tolerated dose (MTD) of PG545
The MTD will be determined by assessing dose limiting toxicities at the end of the first month's treatment. Dose escalation and de-escalation will continue until an MTD is identified. Each cohort of patients will receive weekly doses at a single dose level for the duration of the study.
Time frame: Evaluated at the end of initial 28-day cycle
Number of adverse events by cohort
Time frame: Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment
Severity of adverse events by cohort
Time frame: Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment
Assessment of the anti-tumour activity of PG545 using RECIST criteria
Time frame: Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and then up to four weeks post-treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.