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New mRNA drug takes on HER2 cancers in first human trial

NCT ID NCT07334119

Disease control Sponsor: Myeloid Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing a new mRNA-based drug called MT-304, alone or with the immunotherapy nivolumab, in adults with advanced HER2-expressing solid tumors. The main goals are to check safety, find the right dose, and get a first look at whether it shrinks tumors. About 60 participants will receive the drug every two weeks and be closely monitored.

What this could mean

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

Active substance
MT-304 (mRNA therapy) and nivolumab
What this could lead to
If it works, this could point toward a new treatment option for advanced HER2-expressing cancers.
What could go wrong
This is a very early Phase 1 trial with only 60 participants, so safety and dosing are still being figured out. It may not work or could have 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 60 people

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

Started

Nov 2025

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Aged 18 years or above * Histologically confirmed diagnosis of metastatic or advanced epithelial cancer expressing HER2 (Note: Participants with other tumor types expressing HER2 may be considered pending discussion with the Medical Monitor). * Measurable lesion per RECIST 1.1 criteria. * Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1. * Adequate Organ function Exclusion Criteria: * Known active CNS metastasis and/or carcinomatous meningitis. * Any acute illness including fever. * History of symptomatic congestive heart failure * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Uncontrolled pleural effusion, pericardial effusion, or ascites * Active autoimmune disease not related to prior therapy for primary malignancy that has required systemic therapy in the last 1 year.

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus Biliary Tract Neoplasms breast neoplasm Carcinoma, Ovarian Epithelial cholangiocarcinoma colorectal neoplasm endometrium neoplasm non-small cell lung carcinoma transitional cell carcinoma

As listed by the trial registrant

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

HER2 expressing solid tumors

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

    7 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

Locations

  • Cabrini Health

    RECRUITING

    Melbourne, Victoria, 3144, Australia

  • Calvary Mater Newcastle

    RECRUITING

    Waratah, New South Wales, 2298, Australia

  • Cancer Research SA Pty Ltd

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Icon Cancer Centre South Brisbane

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Linear Clinical Research

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Scientia Clinical Research Ltd

    RECRUITING

    Randwick, New South Wales, 2031, Australia

    Contact Email: •••••@•••••

  • The Kinghorn Cancer Centre

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

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