Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors
Recruiting now · Phase 1
Conditions studied: HER2-Expressing Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT07334119
- Run by
- Myeloid Therapeutics
- People needed
- 60
- Starts
- 2025-11-25
- Expected to finish
- 2028-03-30
- Last updated by the study team
- 2026-05-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- The Kinghorn Cancer Centre — Darlinghurst, New South Wales, Australia (enrolling)
- Scientia Clinical Research Ltd — Randwick, New South Wales, Australia (enrolling)
- Calvary Mater Newcastle — Waratah, New South Wales, Australia (enrolling)
- Icon Cancer Centre South Brisbane — South Brisbane, Queensland, Australia (enrolling)
- Cancer Research SA Pty Ltd — Adelaide, South Australia, Australia (enrolling)
- Cabrini Health — Melbourne, Victoria, Australia (enrolling)
- Linear Clinical Research — Nedlands, Western Australia, Australia (enrolling)
Full record on ClinicalTrials.gov
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