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RecruitingPhase 1NCT07334119

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

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

Sponsor

Myeloid Therapeutics

Enrollment

60 participants

Start Date

Nov 25, 2025

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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.

Interventions

DRUGMT-304

Safety, tolerability, and pharmacokinetics will be evaluated.

DRUGMT-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

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NCT07334119