Actively Recruiting
A First-in-Human Phase 1 Safety and Pharmacokinetic Study of Escalating Doses of ERX-315 in Participants With Advanced Solid Tumors
Led by EtiraRx Australia Pty Ltd · Updated on 2026-05-29
36
Participants Needed
5
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the safety, tolerability, and pharmacokinetics of ERX-315 in adults with advanced solid tumors, including breast, ovarian, pancreatic, endometrial, and liver cancers, who have not responded to approved systemic treatments. This is an open-label Phase 1 trial focused on patients with measurable, advanced, unresectable, or metastatic disease. The study evaluates escalating doses of ERX-315 to understand how the drug behaves in the body and its preliminary safety profile. Participants will receive ERX-315 through intravenous injections twice a week in 21-day treatment cycles. The study includes a dose escalation phase to identify the recommended dose for future trials. ERX-315 dosing starts at 0.4 mg/kg and is increased over time to evaluate safety and side effects. This trial does not include placebo or comparator groups and aims to monitor dose limiting toxicities and adverse events. During the study, participants will undergo regular assessments of safety, including monitoring for side effects, laboratory tests, and evaluation of organ function. Pharmacokinetic measurements such as drug concentration and half-life will be collected to understand drug behavior. Researchers will also assess tumor response and progression. The study period for primary safety outcomes is 21 to 84 days, with ongoing monitoring for up to 84 days. Participants are expected to have a life expectancy over 3 months and will be followed for adverse events and clinical responses during the trial.
CONDITIONS
Brief Title
A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Histologically or cytologically confirmed advanced unresectable and/or metastatic solid tumor, including breast, ovarian, pancreatic, endometrial, and hepatocellular carcinoma
- Measurable disease according to RECIST v1.1
- Adequate baseline organ and hematologic function
- Life expectancy greater than 3 months
You will not qualify if you...
- Received systemic anti-cancer therapy within 4 weeks before first dose of study drug
- Major surgery within 4 weeks before first dose of study drug
- Presence of uncontrolled intercurrent illnesses
- Known history of LIPA deficiency, such as Wolman disease or Cholesterol ester storage disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive ERX-315 as an intravenous injection twice a week over 21-day cycles at escalating doses to evaluate safety and pharmacokinetics.
Twice-weekly visits for ERX-315 infusions per cycle
Trial Site Locations
Total: 5 locations
1
Macquarie University Health
Ryde, New South Wales, Australia, 2109
Actively Recruiting
2
The Kinghorn Cancer Center
Sydney, New South Wales, Australia, 2010
Actively Recruiting
3
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
4
Cancer Research SA
Adelaide, South Australia, Australia, 5000
Actively Recruiting
5
Icon Cancer Centre Adelaide
Adelaide, South Australia, Australia, 5037
Actively Recruiting
Research Team
R
Research Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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