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Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors
Sponsor: Myeloid Therapeutics
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.
Official title: A Phase 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-11-25
Completion Date
2028-03-30
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
MT-304
Safety, tolerability, and pharmacokinetics will be evaluated.
MT-304 + Nivolumab
Combination therapy begins after monotherapy dose clearance by the Safety Review Committee.
Locations (5)
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
Linear Clinical Research
Nedlands, Western Australia, Australia