A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors
NCT ID: NCT06533332
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
15 participants
INTERVENTIONAL
2024-10-14
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ERX-315
Active investigational therapy
ERX-315
Drug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg.
Interventions
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ERX-315
Drug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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EtiraRx Australia Pty Ltd
OTHER
Responsible Party
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Principal Investigators
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Rasha Cosman, MBBS
Role: PRINCIPAL_INVESTIGATOR
The Kinghorn Cancer Centre
Locations
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Macquarie University Health
Ryde, New South Wales, Australia
The Kinghorn Cancer Center
Sydney, New South Wales, Australia
Cancer Research SA
Adelaide, South Australia, Australia
Icon Cancer Centre Adelaide
Adelaide, South Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Other Identifiers
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ERX-315-101
Identifier Type: -
Identifier Source: org_study_id
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