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ERX-315 Clinical Trial Now Open in Australia A new investigational drug for patients with advanced cancer. ERX-315 represents a new potential approach to fighting cancer. Unlike traditional treatments that affect both healthy and cancerous cells, this innovative new investigational drug is designed to specifically target cancer cells by blocking the proteins they need to survive. In laboratory studies, ERX-315 has shown ability to stop cancer growth and kill cancer cells. What Makes ERX-315 Different?

Slide

This clinical trial is open to adults who:
• Are 18 years or older• Have been diagnosed with Advanced/metastatic solid tumor no longer responding to therapy • Have tried other treatments that are no longer controlling the cancer• Your study doctor will confirm full inclusion/exclusion criteria• Both men and women are welcome to participate.

Are You Eligible?

• You will gain access to a new treatment that is not available anywhere else. In fact, ERX-315 can only be given to patients in this clinical trial.• You may benefit from this new treatment• You will receive care from a specialized team of cancer doctors• You will be helping advance research that may benefit others in the future.

Why should I join a clinical trial?

A Phase 1 Trial of ERX-315 in Participants
with Advanced Solid Tumors
Where to enroll:
• The Kinghorn Cancer Center• Cancer Research SAContact: Kelly Mead.+61 (8) 8359 2565 / admin@crsa.au• MQ Health Medical Oncology and Clinical Trials at Macquarie University.Contact: Luke Wood.+61 (2) 9812 2956 / clinicaltrials@mq.edu.au• Icon Cancer Center Adelaide.Contact: Anna Mislang.+61 (8) 8474 0220 / admin.adelaide@icon.team
For full trial details, please visit ClinicalTrials.gov Where can a patient enroll?

Slide What to Expect Comprehensive Support
• Screening to confirm eligibility
• Detailed explanation of everything before you decide
• Time to discuss with family and your regular doctor

Treatment Schedule
• Regular clinic visits for study-medicine administration
• Safety tests, imaging and other assessments per protocol
• Follow-up visits

You Have Control
• You can leave the study at any time, for any reason
• No pressure - the decision is entirely yours

Slide Frequently Asked Questions Q: Is ERX-315 approved?
A: No. ERX-315 is investigational.
Q: What types of cancer is ERX-315 being tested for?
A: It is intended for advanced metastatic solid tumors that have failed one or more therapies.
Q: Will I benefit from being in this study?
A: Participation may or may not benefit you. This Phase 1 study is not designed to determine benefit.
Q: Do I need to be in Australia to participate in the ERX-315 clinical trial?
A: Yes. The only sites currently recruiting are in Australia: The Kinghorn Cancer Center and MQ Health in Sydney and Cancer Research SA in Adelaide. You will need to go to one of these locations for treatment and tests.
Q: Is it safe?
A: Unknown. Safety and tolerability are being studied in Phase 1.
Q: What costs are covered?
A: The study covers the investigational medicine and study-specific procedures. Standard medical care may be billed per site policy. The study team can provide details.
Q: Can I leave the study?
A: Yes. You may withdraw at any time.
Ready to Learn More? Your next step is simple:
• Talk to your oncologist - they can help determine if this trial suits your situation
• Ask questions - we encourage you to learn everything you want to know
• Take your time - there's no rush to decide
For complete eligibility details: visit ClinicalTrials.gov

If you are interested in joining this phase 1 trial of ERX-315 please review ClinicalTrials.gov then contact one of the currently enrolling clinical trial sites to discuss elegibility and scheduling.

Please reference “ERX-315 Phase 1 (NCT06533332)” in your inquiry.
Where to enroll:
• The Kinghorn Cancer Center• Cancer Research SAContact: Kelly Mead.+61 (8) 8359 2565 / admin@crsa.au• MQ Health Medical Oncology and Clinical Trials at Macquarie University.Contact: Luke Wood.+61 (2) 9812 2956 / clinicaltrials@mq.edu.au• Icon Cancer Center Adelaide.Contact: Anna Mislang.+61 (8) 8474 0220 / admin.adelaide@icon.team
Would you like to enroll? Do you have questions?

 

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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.