A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors
Recruiting now · Phase 1
Conditions studied: Advanced Solid Tumor, Metastatic Breast Cancer, Metastatic Ovarian Cancer, Metastatic Endometrial Cancer, Metastatic Liver Cancer, Metastatic Pancreatic Cancer
In brief
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.
Key facts
- Study ID
- NCT06533332
- Run by
- EtiraRx Australia Pty Ltd
- People needed
- 36
- Starts
- 2024-10-14
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Adequate baseline organ function and hematologic function
- Life expectancy >3 months
You may not qualify if…
- 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.
Where it is running
- Macquarie University Health — Ryde, New South Wales, Australia (enrolling)
- The Kinghorn Cancer Center — Sydney, New South Wales, Australia (enrolling)
- Westmead Hospital — Westmead, New South Wales, Australia (enrolling)
- Cancer Research SA — Adelaide, South Australia, Australia (enrolling)
- Icon Cancer Centre Adelaide — Adelaide, South Australia, Australia (enrolling)
Full record on ClinicalTrials.gov
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