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

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

Plain Language Summary

Simplified for easier understanding

This Phase 1 study tests a new drug called ERX-315 in adults with advanced solid tumors — cancers that have spread or cannot be removed by surgery and have not responded to other treatments. ERX-315 is a first-in-class drug that works by targeting a specific pathway in cancer cells related to cholesterol processing inside the cell (a lysosomal cholesterol transport process). This early-phase study is focused on finding a safe dose and understanding how the drug behaves in the body. **You may be eligible if...** - You are 18 or older with a confirmed advanced or metastatic solid tumor — including but not limited to breast, ovarian, pancreatic, endometrial, or liver cancer - Standard treatments are no longer available or working for your cancer - You have measurable disease on a scan - You have adequate organ function and are in reasonably good health (ECOG 0 or 1) - Your expected survival is more than 3 months **You may NOT be eligible if...** - You received systemic cancer treatment within 4 weeks before starting - You had major surgery within 4 weeks before starting - You have a known enzyme deficiency affecting cholesterol storage (Wolman disease or CESD) - You have uncontrolled other serious illnesses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

View Full Details on ClinicalTrials.gov

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NCT06533332


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