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RecruitingPhase 1NCT06533332

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

A First-in-Human, Phase 1 Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy Study of Escalating Doses of ERX-315 in Participants With Advanced Solid Tumors

Sponsor

EtiraRx Australia Pty Ltd

Enrollment

15 participants

Start Date

Oct 14, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Breast CancerAdvanced Solid TumorMetastatic Ovarian CancerMetastatic Endometrial CancerMetastatic Liver CancerMetastatic Pancreatic Cancer

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria4

  • 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.

Interventions

DRUGERX-315

Drug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg.

Locations(4)

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

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NCT06533332

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