Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours

Study Overview
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Brief Summary
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This first-in-human study aims to establish the maximum tolerated dose of 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.

Official Title
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An Open-label, Single Centre Phase I Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours

Conditions
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Advanced Solid Tumours

Intervention / Treatment
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* Drug: PG545


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >=18 years. Histological or cytological documentation of non hematologic, malignant solid tumour. Have failed at least one previous therapeutic regimen. Measurable disease according to RECIST 1.1. Life expectancy >= 12 weeks ECOG Performance Status of 0 or 1 Written, signed and dated informed consent Able and willing to meet all protocol-required treatments, investigations and visits. Have adequate organ function Exclusion Criteria: Clinically significant non-malignant disease. Active CNS metastases. Subjects with uncontrolled diabetes. History of clinically significant adverse drug reaction to heparin or other anti-coagulant agents History of immune-mediated thrombocytopaenia or other platelet abnormalities or other hereditary or acquired coagulopathies. Concomitant use of aspirin (> 150 mg/day), NSAIDs (except COX-2 selective inhibitors), vitamin K antagonists (other than low-dose prophylactic use), heparin within two weeks prior to randomisation, or other anti-platelet drugs. History of severe allergic, anaphylactic or other significant adverse reaction to radiographic contrast media Known seropositivity to the human immunodeficiency virus (HIV) Women who are pregnant or breast-feeding. Women of child-bearing potential and male subjects who are partners of women of childbearing potential who are unable or unwilling to practice a highly effective means of contraception. Active substance abuse Subjects who have received an investigational agent within 28 days prior to Cycle 1 Day 1.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PG545<br> | Drug: PG545<br>* PG545 Lyophilized Powder for Subcutaneous Injection. Patients will be dosed once weekly until they exhibit disease progression, are discontinued for reasons of tolerability, or the study reaches its defined end-point. This study is a dose escalation study with doses of 25 mg to 500 mg planned.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose (MTD) Based on DLT | The primary objective of this study is the determination of the MTD. Due to the premature termination of the study the MTD could not be determined. The outcome measure presented is the number of DLTs per cohort. | Following first 1 month cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PG545, Phase I, Progen, antimetastatic, antiangiogenic, advanced cancer patients, solid tumors, solid tumours