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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PG545 | Experimental | Once weekly, one hour IV infusion of PG545. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PG545 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Evaluated at the end of initial 28-day cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events by cohort | 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 | Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and for four weeks post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Millward, MBBS | Sir Charles Gairdner Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Ltd | Melbourne | Victoria | 3004 | Australia | ||
| Linear Clinical Research Ltd |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29898788 | Derived | Hammond E, Haynes NM, Cullinane C, Brennan TV, Bampton D, Handley P, Karoli T, Lanksheer F, Lin L, Yang Y, Dredge K. Immunomodulatory activities of pixatimod: emerging nonclinical and clinical data, and its potential utility in combination with PD-1 inhibitors. J Immunother Cancer. 2018 Jun 14;6(1):54. doi: 10.1186/s40425-018-0363-5. |
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|
| Assessment of the anti-tumour activity of PG545 using RECIST criteria | Subjects will be followed for the duration of their treatment (an expected average of 12 weeks), and then up to four weeks post-treatment |
| Nedlands |
| Western Australia |
| 6009 |
| Australia |