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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Type, incidence and severity of Adverse Events
Timeframe: Up to 90 days from the last dose of Investigational Medicinal Product (IMP)
Number of Participants With Change From Baseline in Vital Signs (Composite Safety Outcome)
Timeframe: Up to 30 days from the last dose of IMP
Number of Participants With Abnormal Clinical Laboratory Parameters (Composite Safety Outcome)
Timeframe: Up to 30 days from the last dose of IMP
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.
Maximum Tolerated Dose (MTD)
Timeframe: 28 days from the last dose of IMP
Optimal Biological Dose (OBD)
Timeframe: 28 days from the last dose of IMP