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Trial Title:
A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors
NCT ID:
NCT06533332
Condition:
Advanced Solid Tumor
Metastatic Breast Cancer
Metastatic Ovarian Cancer
Metastatic Endometrial Cancer
Metastatic Liver Cancer
Metastatic Pancreatic Cancer
Conditions: Official terms:
Endometrial Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ERX-315
Description:
Drug administered intravenously twice a week at increasing dose levels, with starting
dose of 0.4mg/kg.
Arm group label:
ERX-315
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, who have progressed on prior approved systemic therapies.
Participants will receive ERX-315 as an intravenous (IV) injection twice a week, over
21-day cycles.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Kinghorn Cancer Center
Address:
City:
Sydney
Zip:
2010
Country:
Australia
Status:
Recruiting
Start date:
October 14, 2024
Completion date:
August 30, 2025
Lead sponsor:
Agency:
EtiraRx Australia Pty Ltd
Agency class:
Other
Source:
EtiraRx Australia Pty Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06533332
