NCT06533332 A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors
| NCT ID | NCT06533332 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | EtiraRx Australia Pty Ltd |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2024-10-14 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2024-10-14 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Rasha Cosman, MBBS
PRINCIPAL INVESTIGATOR
The Kinghorn Cancer Centre
Frequently Asked Questions
Who can join the NCT06533332 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06533332 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06533332 currently recruiting?
Yes, NCT06533332 is actively recruiting participants. Contact the research team at contact@etira.life for enrollment information.
Where is the NCT06533332 trial being conducted?
This trial is being conducted at Ryde, Australia, Sydney, Australia, Westmead, Australia, Adelaide, Australia and 1 additional location.
Who is sponsoring the NCT06533332 clinical trial?
NCT06533332 is sponsored by EtiraRx Australia Pty Ltd. The principal investigator is Rasha Cosman, MBBS at The Kinghorn Cancer Centre. The trial plans to enroll 36 participants.