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New drug ERX-315 enters first human tests for tough cancers

NCT ID NCT06533332

Disease control Sponsor: EtiraRx Australia Pty Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests the safety of a new drug called ERX-315 in 36 adults with advanced solid tumors (like breast, ovarian, or pancreatic cancer) that have stopped responding to standard treatments. Participants receive the drug intravenously twice a week at increasing doses. The main goal is to find a safe dose and check for side effects, not yet to prove it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ERX-315
What this could lead to
If it works, this could point toward a new treatment option for advanced solid tumors that no longer respond to standard therapies.
What could go wrong
This is a very early Phase 1 trial with only 36 participants, focused on safety and dosing. It is too soon to know if ERX-315 will be effective or have manageable side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm endometrial carcinoma endometrium neoplasm liver cancer Liver Neoplasms malignant pancreatic neoplasm neoplasm ovarian cancer pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Metastatic breast cancer Metastatic endometrial cancer Metastatic liver cancer Metastatic ovarian cancer Metastatic pancreatic cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Cancer Research SA

    RECRUITING

    Adelaide, South Australia, 5000, Australia

    Contact Email: •••••@•••••

  • Icon Cancer Centre Adelaide

    RECRUITING

    Adelaide, South Australia, 5037, Australia

  • Macquarie University Health

    RECRUITING

    Ryde, New South Wales, 2109, Australia

    Contact Email: •••••@•••••

  • The Kinghorn Cancer Center

    RECRUITING

    Sydney, New South Wales, 2010, Australia

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia

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