Testing MT-304, alone or with nivolumab, in advanced solid tumors that express HER2
Tests MT-304, alone or with nivolumab, in adults with advanced HER2-expressing tumors.
Plain-language title generated from the registry record
Registry title: Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors
Key facts
- Where
- Adelaide, Darlinghurst, Melbourne, Nedlands, Randwick, South Brisbane, and Waratah, AustraliaSee the 7 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic epithelial cancer that expresses HER2, to test the safety of MT-304 alone or with nivolumab.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Metastatic or advanced epithelial cancer that expresses HER2, confirmed by tissue examination; a lesion that can be measured per RECIST 1.1; ECOG performance status 0 or 1
- Biomarker or test result
- The cancer must express HER2
Main reasons for not taking part
- Known active cancer spread to the brain or spinal cord, or cancer in the membranes around the brain (carcinomatous meningitis)
- Any acute illness, including fever
- History of heart failure with symptoms (symptomatic congestive heart failure)
- History of pneumonitis or interstitial lung disease that needed steroids, or current pneumonitis or interstitial lung disease
- Uncontrolled fluid around the lungs or heart, or in the abdomen (ascites)
Read by machine on 9 November 2026.
Where in Australia
- Cancer Research SA Pty LtdAdelaide, AustraliaTaking people
- The Kinghorn Cancer CentreDarlinghurst, AustraliaTaking people
- Cabrini HealthMelbourne, AustraliaTaking people
- Linear Clinical ResearchNedlands, AustraliaTaking people
- Scientia Clinical Research LtdRandwick, AustraliaTaking people
- Icon Cancer Centre South BrisbaneSouth Brisbane, AustraliaTaking people
- Calvary Mater NewcastleWaratah, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Myeloid Therapeutics
- Trial code
- NCT07334119
- Record updated
- 20 May 2026
- Original description
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:Read full original descriptionShow less
A Phase 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors
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.
Inclusion: 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: Active autoimmune disease not related to prior therapy for primary malignancy that has required systemic therapy in the last 1 year; 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; Known active CNS metastasis and/or carcinomatous meningitis; Uncontrolled pleural effusion, pericardial effusion, or ascites.