A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors

May 27, 2026 updated by: EtiraRx Australia Pty Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Ryde, New South Wales, Australia, 2109
        • Recruiting
        • Macquarie University Health
        • Contact:
        • Principal Investigator:
          • Danusha Sabanathan, FRACP PhD
      • Sydney, New South Wales, Australia, 2010
        • Recruiting
        • The Kinghorn Cancer Center
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital
        • Contact:
          • Jeremy Mo, MD
          • Phone Number: (02) 8890 6666
        • Principal Investigator:
          • Jeremy Mo, MD
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Cancer Research SA
        • Contact:
        • Principal Investigator:
          • Rohit Joshi, MBBS, FRACP
      • Adelaide, South Australia, Australia, 5037
        • Recruiting
        • Icon Cancer Centre Adelaide
        • Contact:
        • Principal Investigator:
          • Anna Mislang, MBBS, FRACP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ERX-315
Active investigational therapy
Drug: ERX-315
Drug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
21 days
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.
84 days
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.
84 days
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
84 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of pharmacokinetic outcome measure of Area under the plasma concentration versus time curve (AUC).
Time Frame: 21 days
AUC will be determined by non-compartmental analysis and assessed after single and multiple doses of drug
21 days
Assessment of pharmacokinetic outcome measure of Peak Plasma concentration (Cmax)
Time Frame: 21 days
Cmax will be determined by non-compartmental analysis and assessed after single and multiple doses of drug
21 days
Assessment of pharmacokinetic outcome measure of drug half-life (t1/2)
Time Frame: 21 days
t1/2 will be assessed after single and multiple doses of drug
21 days
Antitumor activity of ERX-315 based on Objective response rate (ORR)
Time Frame: 84 days
ORR will be assessed by RECIST v1.1
84 days
Antitumor activity of ERX-315 based on Best Overall Clinical Response (BOCR)
Time Frame: 84 days
BOCR will be assessed by RECIST v1.1
84 days
Antitumor activity of ERX-315 based on Duration of response (DOR)
Time Frame: 84 days
DOR will be assessed by RECIST v1.1 and time frame of response
84 days
Antitumor activity of ERX-315 based on Progression-free survival (PFS)
Time Frame: 84 days
PFS will be assessed by RECIST v1.1 and time frame of response
84 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Impact on patient reported symptoms using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire
Time Frame: 84 days
Effect of ERX-315 on the changes from baseline in patient reported symptoms using the PRO-CTCAE Questionnaire
84 days
Serum LIPA lipase activity as pharmacodynamic markers of ERX-315 activity
Time Frame: 84 days
The effect of ERX-315 on serum LIPA lipase activity may be evaluated
84 days
Circulating tumor DNA levels as pharmacodynamic markers of ERX-315 activity
Time Frame: 84 days
The effect of ERX-315 on circulating tumor DNA levels may be evaluated
84 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
EtiraRx Australia Pty Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rasha Cosman, MBBS, The Kinghorn Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ERX-315-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Breast Cancer

Clinical Trials on ERX-315

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings