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

Launched by ETIRARX AUSTRALIA PTY LTD · Jul 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ERX-315 for people with advanced solid tumors, which are cancers that form in tissues like the breast, ovaries, pancreas, liver, and uterus. This trial is in the early stages, known as Phase 1, and aims to find out if ERX-315 is safe for patients whose cancer has not responded to standard treatments. Researchers are currently looking for participants who are at least 18 years old and have a specific type of cancer that cannot be treated with existing therapies, meaning their cancer has spread or cannot be removed with surgery.

To participate, patients need to have measurable cancer, good overall health status, and a life expectancy of more than three months. They should not have received certain other cancer treatments or undergone major surgeries recently. If someone joins this trial, they will be monitored closely for any side effects from the new treatment. This trial is important as it could lead to new options for patients with difficult-to-treat cancers.

Gender

ALL

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.