Status:
RECRUITING
A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors
Lead Sponsor:
EtiraRx Australia Pty Ltd
Conditions:
Advanced Solid Tumor
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
The goal of this open-label, dose escalation and cohort expansion Phase 1 clinical trial is to determine the safety, tolerability and pharmacokinetics of ERX-315 in patients with advanced solid tumors...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06533332
Start Date
October 14 2024
End Date
June 30 2026
Last Update
September 18 2025
Active Locations (4)
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1
Macquarie University Health
Ryde, New South Wales, Australia, 2109
2
The Kinghorn Cancer Center
Sydney, New South Wales, Australia, 2010
3
Cancer Research SA
Adelaide, South Australia, Australia, 5000
4
Icon Cancer Centre Adelaide
Adelaide, South Australia, Australia, 5037