Testing ERX-315 in patients with advanced solid tumors
Official title: 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
Run by EtiraRx Australia Pty Ltd · NCT06533332 · Data updated 2026-11-12
This study is testing a new treatment called ERX-315 to see if it is safe and effective for people with advanced solid tumors that haven't responded to other therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | EtiraRx Australia Pty Ltd Academic / other |
| Locations | 5 sites (Ryde, New South Wales and 4 other locations) |
| Status | Recruiting |
| Started | October 14, 2024 |
| Main results expected | December 30, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | May 29, 2026 |
| Trial ID | NCT06533332 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with advanced unresectable or metastatic solid tumors that have failed prior systemic therapies.
✕Probably not a fit
Patients who have received systemic anti-cancer therapy within 4 weeks prior to the study or have uncontrolled intercurrent illnesses may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 clinical trial aims to evaluate the safety, tolerability, and pharmacokinetics of ERX-315 in patients suffering from advanced solid tumors that have not responded to standard therapies. The study is open-label and involves a dose escalation and cohort expansion approach, where participants will receive ERX-315 via intravenous injection twice a week over 21-day cycles. The trial focuses on patients with various types of metastatic cancers, including breast, ovarian, endometrial, and liver cancers.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have exhausted existing treatment options.
How similar studies have gone: While this approach is novel in its specific application, similar studies targeting advanced solid tumors have shown promise in the past.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Macquarie University Health
Ryde, New South Wales, Australia Recruiting -
The Kinghorn Cancer Center
Sydney, New South Wales, Australia Recruiting -
Westmead Hospital
Westmead, New South Wales, Australia Recruiting -
Cancer Research SA
Adelaide, South Australia, Australia Recruiting -
Icon Cancer Centre Adelaide
Adelaide, South Australia, Australia Recruiting
Study contacts
- Principal investigator: Rasha Cosman, MBBS — The Kinghorn Cancer Centre
- Study coordinator: Research Director
- Email: contact@etira.life
- Phone: 01 469 600 6603
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.