Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Adva… (NCT07334119) | Clinical Trial Compass
RecruitingPhase 1
Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors
Australia60 participantsStarted 2025-11-25
Plain-language summary
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?
* What is the recommended Phase 2 dose (RP2D) of MT-304?
Participants will:
* Receive MT-304 alone (every 14 days) or with nivolumab (every 28 days).
* Attend regular clinic visits for assessments and monitoring.
* Continue treatment until disease progression, unacceptable toxicity, or study discontinuation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since MT-304 is a Phase 1 trial focused primarily on finding a safe dose rather than proving the treatment works, what does that mean for me personally in terms of the balance between potential benefit and unknown risks?
2The trial is measuring things like heart rhythm changes on ECG, abnormal lab values, and vital sign shifts as key safety outcomes — given my current heart health and overall condition, am I at higher risk for any of these specific side effects?
3Because researchers are still trying to establish both the maximum tolerated dose and the optimal biological dose, there's a chance my dose could be adjusted during the trial — how would that be managed, and what happens if I experience a serious adverse event?
4Before considering this early-phase trial, is there a standard HER2-targeted treatment — like trastuzumab or other approved therapies — that might be worth trying first given my tumor type and HER2 expression level?
5What does 'HER2-expressing' mean for my specific cancer, and how confident is my care team that my tumor profile makes this trial worth discussing as an option for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Type, incidence and severity of Adverse Events
Timeframe: Up to 90 days from the last dose of Investigational Medicinal Product (IMP)
2
Number of Participants With Change From Baseline in Vital Signs (Composite Safety Outcome)
Timeframe: Up to 30 days from the last dose of IMP
3
Number of Participants With Abnormal Clinical Laboratory Parameters (Composite Safety Outcome)
Timeframe: Up to 30 days from the last dose of IMP
4
Number of Participants With Change From Baseline in ECG Parameters (Composite Safety Outcome)
Timeframe: Screening through Day 28, with assessments performed on Screening, Day 1 (pre-dose), and Day 28.