Advanced Solid TumorPhase 1NCT06533332
A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors
A Phase 1 study testing ERX-315 in people with Advanced Solid Tumor and Metastatic Breast Cancer, run by EtiraRx Australia Pty Ltd at 5 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Metastatic Breast Cancer, Metastatic Ovarian Cancer
- What is being tested?
- ERX-315
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesAustralia
- Study dates
- 14 Oct 2024to 30 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Australia5 sites, 5 recruiting
- Recruiting
Cancer Research SA
Adelaide, South Australia, 5000
Kelly Mead, 08 8359 2565, admin@crsa.au
Rohit Joshi, MBBS, FRACP
- Recruiting
Icon Cancer Centre Adelaide
Adelaide, South Australia, 5037
08 8474 0220, admin.adelaide@icon.team
Anna Mislang, MBBS, FRACP
- Recruiting
Macquarie University Health
Ryde, New South Wales, 2109
+61 (2) 9812 3000, reception@muh.org.au
Danusha Sabanathan, FRACP PhD
- Recruiting
The Kinghorn Cancer Center
Sydney, New South Wales, 2010
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Jeremy Mo, MD, (02) 8890 6666
Jeremy Mo, MD
About this study
Official title: A First-in-Human, Phase 1 Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy Study of Escalating Doses of ERX-315 in Participants With Advanced Solid Tumors
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.
Read the detailed description
The goal of this open-label, dose escalation and cohort expansion Phase 1 clinical trial is to determine the safety, tolerability and pharmacokinetics of ERX-315 in patients with advanced solid tumors, who have progressed on prior approved systemic therapies. Participants will receive ERX-315 as an intravenous (IV) injection twice a week, over 21-day cycles.
- Conditions
- Advanced Solid Tumor, Metastatic Breast Cancer, Metastatic Ovarian Cancer, Metastatic Endometrial Cancer, Metastatic Liver Cancer, Metastatic Pancreatic Cancer
- Being tested
- ERX-315
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Liver Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERX-315Drug
Drug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| ERX-315 | Experimental | Active investigational therapy Receives: Drug: ERX-315 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities of ERX-315
First cycle dose limiting toxicities characterized by type, frequency, severity, timing, seriousness, and relationship to study drug
Measured: 21 days
Incidence of Adverse Events as a measure of safety and tolerability of ERX-315
Adverse events as characterized by type, frequency, severity (grade), timing, seriousness, and relationship to study drug.
Measured: 84 days
Incidence of laboratory abnormalities as a measure of safety and tolerability of ERX-315
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Measured: 84 days
Determination of the recommended phase 2 dose
To determine the recommended phase 2 dose(s) for additional evaluation of ERX-315 in clinical trials for participants with advanced solid tumors
Measured: 84 days
Secondary outcomes (7)
Assessment of pharmacokinetic outcome measure of Area under the plasma concentration versus time curve (AUC).
AUC will be determined by non-compartmental analysis and assessed after single and multiple doses of drug
Measured: 21 days
Assessment of pharmacokinetic outcome measure of Peak Plasma concentration (Cmax)
Cmax will be determined by non-compartmental analysis and assessed after single and multiple doses of drug
Measured: 21 days
Assessment of pharmacokinetic outcome measure of drug half-life (t1/2)
t1/2 will be assessed after single and multiple doses of drug
Measured: 21 days
Antitumor activity of ERX-315 based on Objective response rate (ORR)
ORR will be assessed by RECIST v1.1
Measured: 84 days
Antitumor activity of ERX-315 based on Best Overall Clinical Response (BOCR)
BOCR will be assessed by RECIST v1.1
Measured: 84 days
Antitumor activity of ERX-315 based on Duration of response (DOR)
DOR will be assessed by RECIST v1.1 and time frame of response
Measured: 84 days
Antitumor activity of ERX-315 based on Progression-free survival (PFS)
PFS will be assessed by RECIST v1.1 and time frame of response
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start14 Oct 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EtiraRx Australia Pty Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rasha Cosman, MBBS, Principal investigator, The Kinghorn Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533332
- Sponsor's protocol ID
- ERX-315-101
- Status last verified
- May 2026
- First submitted
- 22 Jul 2024
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Phase 1 Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy Study of Escalating Doses of ERX-315 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06533332
- Acronym / sponsor ID
- ERX-315-101
- Conditions
- Advanced Solid Tumor, Metastatic Breast Cancer, Metastatic Ovarian Cancer, Metastatic Endometrial Cancer, Metastatic Liver Cancer, Metastatic Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- EtiraRx Australia Pty LtdUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of this open-label, dose escalation and cohort expansion Phase 1 clinical trial is to determine the safety, tolerability and pharmacokinetics of ERX-315 in patients with advanced solid tumors, who have progressed on prior approved systemic therapies. Participants will receive ERX-315 as an intravenous (IV) injection twice a week, over 21-day cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERX-315 | Experimental | Drug: ERX-315Active investigational therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERX-315Drug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg. | Drug | ERX-315 |
Primary outcome
Incidence of Dose Limiting Toxicities of ERX-315
Time frame: 21 days
First cycle dose limiting toxicities characterized by type, frequency, severity, timing, seriousness, and relationship to study drug
Incidence of Adverse Events as a measure of safety and tolerability of ERX-315
Time frame: 84 days
Adverse events as characterized by type, frequency, severity (grade), timing, seriousness, and relationship to study drug.
Incidence of laboratory abnormalities as a measure of safety and tolerability of ERX-315
Time frame: 84 days
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Determination of the recommended phase 2 dose
Time frame: 84 days
To determine the recommended phase 2 dose(s) for additional evaluation of ERX-315 in clinical trials for participants with advanced solid tumors
7 secondary outcomes
Assessment of pharmacokinetic outcome measure of Area under the plasma concentration versus time curve (AUC).
Time frame: 21 days
Assessment of pharmacokinetic outcome measure of Peak Plasma concentration (Cmax)
Time frame: 21 days
Assessment of pharmacokinetic outcome measure of drug half-life (t1/2)
Time frame: 21 days
Antitumor activity of ERX-315 based on Objective response rate (ORR)
Time frame: 84 days
Antitumor activity of ERX-315 based on Best Overall Clinical Response (BOCR)
Time frame: 84 days
Antitumor activity of ERX-315 based on Duration of response (DOR)
Time frame: 84 days
Antitumor activity of ERX-315 based on Progression-free survival (PFS)
Time frame: 84 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rasha Cosman, MBBS principal investigator
The Kinghorn Cancer Centre
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ERX-315 in people with Advanced Solid Tumor and Metastatic Breast Cancer, run by EtiraRx Australia Pty Ltd at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Director (01 469 600 6603, contact@etira.life), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose Limiting Toxicities of ERX-315 (time frame: 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.