A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors
Recruiting · NCT06533332 · Interventional (participants receive a specific treatment) · Lead sponsor: EtiraRx Australia Pty Ltd
View the official record on ClinicalTrials.gov →Interventions studied
ERX-315
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
5 locations listed.
- Macquarie University Health - Ryde, New South Wales, Australia
- The Kinghorn Cancer Center - Sydney, New South Wales, Australia
- Westmead Hospital - Westmead, New South Wales, Australia
- Cancer Research SA - Adelaide, South Australia, Australia
- Icon Cancer Centre Adelaide - Adelaide, South Australia, Australia