Clinical Trial

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

Recruiting Phase 1
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2026-01-02; most recent amendment 2026-05-18.
Trial Details
NCT Number NCT07334119
Lead Sponsor Myeloid Therapeutics
Collaborators: CREATE Medicines
Conditions HER2-Expressing Solid Tumors
Enrollment 60 participants
Start Date 2025-11-25
Primary Completion 2027-01-31 (estimated)
Study Completion 2028-03-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-20