Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors

Summary

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.

Eligibility

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.

Conditions4

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