Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors
Recruiting · NCT07334119 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
MT-304MT-304 + Nivolumab
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 is running
7 locations listed.
- The Kinghorn Cancer Centre - Darlinghurst, New South Wales, Australia
- Scientia Clinical Research Ltd - Randwick, New South Wales, Australia
- Calvary Mater Newcastle - Waratah, New South Wales, Australia
- Icon Cancer Centre South Brisbane - South Brisbane, Queensland, Australia
- Cancer Research SA Pty Ltd - Adelaide, South Australia, Australia
- Cabrini Health - Melbourne, Victoria, Australia
- Linear Clinical Research - Nedlands, Western Australia, Australia