Conditions: Advanced Solid Tumours
Keywords: PG545 Phase I Progen antimetastatic antiangiogenic advanced cancer patients solid tumors solid tumours
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 4
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: PG545
Intervention descriptions: intervention 1: 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.

Protocol document: