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Tests treatment safety and results for HER2-Expressing Solid Tumors
Official title Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors
ClinicalTrials.gov ID: NCT07334119
What this study is testing
What is MT-304?
MT-304 is an investigational medicine, being studied as a potential treatment for her2-expressing solid tumors.
Also referred to as mRNA-LNP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial is designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MT-304 in adults with advanced HER2-expressing solid tumors. The main questions it aims to answer are: What is the safety profile of MT-304 when administered alone or with nivolumab?
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged 18 years or above
- Histologically confirmed diagnosis of metastatic or advanced epithelial cancer expressing HER2 (Note: Participants with other tumor types expressing...
- Measurable lesion per RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1.
- Adequate Organ function
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Darlinghurst, New South Wales, Australia
- Randwick, New South Wales, Australia
- Waratah, New South Wales, Australia
- South Brisbane, Queensland, Australia
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
- Nedlands, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Darlinghurst, New South Wales, Australia; Randwick, New South Wales, Australia; Waratah, New South Wales, Australia; South Brisbane, Queensland, Australia; Adelaide, South Australia, Australia; Melbourne, Victoria, Australia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.