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Recruiting Phase 1 NCT06533332

A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors

Phase 1 – testing safety in a small group of people
Conditions: Advanced Solid Tumor Metastatic Breast Cancer Metastatic Ovarian Cancer Metastatic Endometrial Cancer Metastatic Liver Cancer Metastatic Pancreatic Cancer

Sponsor: EtiraRx Australia Pty Ltd

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Overview
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.
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.
Who can participate
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.
Locations 1
Australia (1)
Macquarie University Health
Ryde , New South Wales
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
14.10.2024
Completion date
30.06.2026
Registry ID
NCT06533332
Source
anzctr
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