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
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?
Trial 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.