Testing MT-304, an mRNA lipid-nanoparticle anti-HER2 CAR therapy, in adults with advanced HER2-expressing solid tumors.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter Phase 1 study administers MT-304 — an mRNA-encoded anti-HER2 chimeric antigen receptor delivered in lipid nanoparticles — as monotherapy (every 14 days) or combined with nivolumab (MT-304 every 14 days; nivolumab every 28 days). A Bayesian Optimal Interval (BOIN) dose-escalation design overseen by a Safety Review Committee will define the recommended Phase 2 dose. The trial collects safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity by RECIST 1.1, with regular labs and clinic assessments and up to two years of follow-up. Dosing adjustments are allowed based on clinical benefit and observed toxicities.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Kinghorn Cancer Centre
  Darlinghurst, New South Wales, Australia Recruiting
• Scientia Clinical Research Ltd
  Randwick, New South Wales, Australia Recruiting
• Calvary Mater Newcastle
  Waratah, New South Wales, Australia Recruiting
• Icon Cancer Centre South Brisbane
  South Brisbane, Queensland, Australia Recruiting
• Cancer Research SA Pty Ltd
  Adelaide, South Australia, Australia Recruiting
• Cabrini Health
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Study coordinator: Project Manager
• Email: MTX-HER2-304_ClinicalStudy@novotech-cro.com
• Phone: +61731376255

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.