NCT06533332RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 22 Jul 2024
- Start date
- 14 Oct 2024
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- EtiraRx Australia Pty Ltd
- Diseases
- Endometrial cancer, Pancreatic cancer, Metastatic breast cancer, Liver and biliary tract cancer, Ovarian cancer
- NCT number
- NCT06533332
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 36
- From 14 Oct 2024 to the primary completion date, 30 Dec 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.
Other illness
- Systemic anti cancer therapy 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Research SA Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Icon Cancer Centre Adelaide Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Macquarie University Health Coordinator of this site? Confirm its status | Ryde | Australia | Recruiting |
| The Kinghorn Cancer Center Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.