now recruiting in Australia
A cancer patient may be able to participate in the trial if they meet eligibility criteria including:
- Confirmed metastatic cancer, for which approved therapies are no longer effective
- Adequate performance status
- Adequate baseline organ function, as measured by laboratory values
- No ongoing therapy, uncontrolled illnesses or infections
The study doctor will review the complete list of the study’s criteria with you to determine your eligibility. For more details, see below.
Who may participate
The Kinghorn Cancer Center
Cancer Research SA
CTV or ClinicalTrials.gov
• You are at least 18 years old
• You have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. In other words, you are able to care for yourself and perform light or sedentary tasks without restriction due to the effects of your cancer.
• You have a confirmed advanced tumor that is unresectable (cannot be operated on) and / or metastatic (has spread from its original location).
• You must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. In other words, your tumors need to be large enough to measure and within a certain range of sizes. Your doctor or the study doctor will determine if your tumor(s) fit these criteria.
• You have adequate baseline organ function and hematologic function. In other words, your organs and blood are sufficiently healthy. Laboratory tests will determine this.
• You have a life expectancy of at least three months.
Furthermore, you must not have any of the following criteria:
• You have had systemic anti cancer therapy or major surgery within 4 weeks of first dose of study drug
• You have other uncontrolled illnesses
• You have a known history of lysosomal acid lipase deficiency, such as Wolman disease or Cholesterol ester storage disease.
If you are accepted, you will be in the clinical study for up to 12 weeks (84 days). You would receive ERX-315 twice a week via IV.
• If I am in this study will I definitely get treatment with ERX-315 or might I get a placebo?
Everyone in this phase one cancer trial will be given ERX-315. This is not a randomized trial.
• Do I need to be in Australia to participate in the ERX-315 clinical trial?
Yes. The only sites currently recruiting are in Australia: The Kinghorn Cancer Center in Sydney and Cancer Research SA in Adelaide. You will need to go to one of these locations for treatment and tests.
• You mentioned this is a Phase 1 clinical trial. What does that mean?
A Phase 1 study is done to find the highest dose of the new treatment that can be given safely without causing severe side effects.
• How does ERX-315 work?
We cannot say for certain how it works in humans. In laboratory mice, ERX-315 killed cancer cells by inducing endoplasmic reticulum (ER) stress. This is a cellular response to the accumulation of unfolded or misfolded proteins in the ER which can lead to the death of the cells. For more information, see Our Science.
For more general Q&A on clinical trials, see clinicaltrials.gov.
The Kinghorn Cancer Center
Cancer Research SA
Where to find us
Dallas Office:
3033 Irving Blvd,
Dallas. TX. 75247
Mailing Address:
3060 Pegasus Park Dr.
Dallas. TX. 75247