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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 approach to fighting cancer. Unlike traditional treatments that affect both healthy and cancerous cells, this innovative therapy is designed to specifically target cancer cells by blocking the proteins they need to survive. In laboratory studies, ERX-315 has shown remarkable 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 solid tumors including Breast, Ovarian, Pancreatic, Uterine or Liver cancer• Have cancer that has spread (metastatic) • Have tried other treatments that are no longer controlling the cancer• 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
For full trial details, please visit ClinicalTrials.gov Where can a patient enroll?

Slide What to Expect Clear Treatment Schedule
• Two visits per week for one-hour IV treatments
• Regular check-ups to monitor your progress

Comprehensive Support
• Detailed explanation of everything before you decide
• Time to discuss with family and your regular doctor
• 24/7 access to your study team for questions or concerns

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: Has anyone taken ERX-315 before?
A: This is the first human trial, which means you'd be among the first to potentially benefit from this innovative approach. Early safety testing has shown only mild changes in blood tests.
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 including breast, ovarian, pancreatic, endometrial, and liver cancers.
Q: How long will treatment last?
A: Treatment continues as long as you're benefiting and feeling well. You control the timeline.
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: What about side effects?
A: As with any new treatment, side effects are possible. Our team monitors you closely, and you'll receive immediate care for any concerns at no cost to you.
Q: Will ERX-315 work for me?
A: We do not know if this treatment will work for you. The mechanism of action of ERX-315 is different from conventional cancer treatments. The only way to see if ERX-315 works for you is to participate in the clinical trial.
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

Slide A Message of Hope When you're facing advanced cancer, every day matters. This trial represents years of scientific research coming together to offer new possibilities. While we cannot guarantee outcomes, we can promise you will receive exceptional care while accessing a new treatment. Your participation doesn't just offer hope for you - it paves the way for future cancer treatments.

For U.S. patients: A similar trial may open in America by 2026. Stay connected with your oncology team for updates.

If you are interested in joining this phase 1 cancer trial of ERX-315 for patients with advanced solid tumors, discuss the trial with your doctor or contact one of the currently enrolling clinical trial sites:
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
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.