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

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

Trial Details

NCT ID
NCT07334119
Phase
PHASE1
Sponsor
Myeloid Therapeutics
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • MT-304
  • MT-304 + Nivolumab
Locations (sample)
  • Randwick, New South Wales, Australia|-33.91439,151.24895
  • Waratah, New South Wales, Australia|-32.90667,151.72647
  • South Brisbane, Queensland, Australia|-27.48034,153.02049
  • Adelaide, South Australia, Australia|-34.92866,138.59863
  • Melbourne, Victoria, Australia|-37.814,144.96332

Key Eligibility Criteria

  • Aged 18 years or above
  • Histologically confirmed diagnosis of metastatic or advanced epithelial cancer expressing HER2 (Note: Participants with other tumor types expressin…
  • Measurable lesion per RECIST 1.1 criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1.

For full eligibility, visit ClinicalTrials.gov.

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