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
Locations
5Sponsors and collaborators
EtiraRx Australia Pty Ltd
Lead sponsor