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

RecruitingPhase 1Ages 18 Years - anyAllMyeloid Therapeutics
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • MT-304
  • MT-304 + Nivolumab
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Where

7 sites
The Kinghorn Cancer Centre
Darlinghurst, Australia
Scientia Clinical Research Ltd
Randwick, Australia
Calvary Mater Newcastle
Waratah, Australia
Icon Cancer Centre South Brisbane
South Brisbane, Australia
Cancer Research SA Pty Ltd
Adelaide, Australia
Cabrini Health
Melbourne, Australia
Linear Clinical Research
Nedlands, Australia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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