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

Last updated: November 18, 2024
Sponsor: EtiraRx Australia Pty Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Liver Metastases

Liver Cancer

Breast Cancer

Treatment

ERX-315

Clinical Study ID

NCT06533332
ERX-315-101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must be at least 18 years of age at the time of signing the informedconsent.

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

  • Patients must have histologically or cytologically confirmed solid tumor, primarilyincluding but not limited to breast, ovarian, pancreatic, endometrial andhepatocellular carcinoma, that is advanced unresectable and/or metastatic diseasefor whom standard therapies do not exist or are no longer effective

  • Patients must have measurable disease as per Response Evaluation Criteria in SolidTumors (RECIST) v1.1.

  • Adequate baseline organ function and hematologic function

  • Life expectancy >3 months

Exclusion

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 studydrug.

  • Uncontrolled intercurrent illnesses

  • Known history of LIPA deficiency, such as Wolman disease or Cholesterol esterstorage disease.

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: ERX-315
Phase: 1
Study Start date:
October 14, 2024
Estimated Completion Date:
August 30, 2025

Study 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.

Connect with a study center

  • The Kinghorn Cancer Center

    Sydney, New South Wales 2010
    Australia

    Active - Recruiting

  • Cancer Research SA

    Adelaide, South Australia 5000
    Australia

    Site Not Available

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