About this trial

This is a Phase 1 study to assess the safety of ERX-315 in patients with advanced solid tumors that have failed approved systemic therapies.

Eligibility criteria

Qualifiers

Patients must be at least 18 years of age at the time of signing the informed consent.

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Patients must have histologically or cytologically confirmed solid tumor, primarily including but not limited to breast, ovarian, pancreatic, endometrial and hepatocellular carcinoma, that is advanced unresectable and/or metastatic disease for whom standard therapies do not exist or are no longer effective

Patients must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Disqualifiers

Systemic anti cancer therapy within 4 weeks of first dose of study drug

Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.

Uncontrolled intercurrent illnesses

Known history of LIPA deficiency, such as Wolman disease or Cholesterol ester storage disease.

Trial design

Treatments tested in this trial

  • ERX-315

Treatment groups

36 Participants
are divided into 1 treatment group

Locations

5
Macquarie University Health2109, RydeNew South Wales, Australia
The Kinghorn Cancer Center2010, SydneyNew South Wales, Australia
Westmead Hospital2145, WestmeadNew South Wales, Australia
Cancer Research SA5000, AdelaideSouth Australia, Australia

Sponsors and collaborators

EtiraRx Australia Pty Ltd

Lead sponsor