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.
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.
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.
Myeloid Therapeutics
Lead sponsor
CREATE Medicines
Collaborator