A Phase 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including Hepatocellular Carcinoma
Sponsor study identifier
interventional
70
3 countries
9
Study Start
July 1, 2024
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a multicenter, open-label, Phase 1, first-in-human, dose-escalation study designed to assess the safety, tolerability and define the RP2D of MT-303 alone (Module 1) and in combination with Atezo/Bev (Module 2) in participants with advanced hepatocellular carcinoma expressing GPC3.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 24, 2024
Actual (reported)June 27, 2024
Actual (reported)July 1, 2024
Actual (reported)December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Type, incidence and severity of Adverse Events
Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0
Up to 2 years from the last dose of Investigational Medicinal Product (IMP)
Recommended Phase 2 Dose (RP2D)
The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
28 days from the last dose of IMP
Optimal Biological dose (OBD)
The OBD will be determined using dose limiting toxicities (DLTs) and all other available study data
21 days from the last dose of IMP
Change from baseline in vital signs
Temperature, weight, height, pulse rate and blood pressure will be assessed
Up to 30 days from the last dose of IMP
Change in laboratory parameters
Hematology, chemistry, coagulation, virology and urine analysis will be assessed.
Up to 30 days from the last dose of IMP
Pharmacokinetics (PK)
Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2.
Pharmacokinetics (PK)
Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2.
Pharmacokinetics (PK)
Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2.
Pharmacokinetics (PK)
Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2.
Pharmacokinetics (PK)
Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2.
Participants will receive MT-303 through intravenous infusion.
Participants will receive MT-303 in combination with Atezo/Bev through intravenous infusion.
MT-303
MT-303 in combination with Atezo/Bev
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
MT-303 +Atezolizumab + Bevacizumab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordSt Vincent's Hospital
Sydney, New South Wales, 2010, Australia
Integrated Clinical Oncology Network (ICON) Pty Ltd
Woolloongabba, Queensland, 4102, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Matthew Maurer, MD
Myeloid Therapeutics
First Submitted
June 24, 2024
First Posted
June 27, 2024
Study Start
July 1, 2024
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial for First-line Treatment of Hepatocellular Carcinoma
Change from baseline in ECG parameters
Screening, Day 1 and Day 15
Contact the study team to confirm eligibility.
Linear Clinical Research
Murdoch, Western Australia, 6150, Australia
Pusan National Univesity Hospital
Busan, South Korea
Cha University Bundang Medical Center
Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, South Korea
National Taiwan University Hospital
Taipei, Taiwan
Taipei Tzu Chi Hospital
Taipei, Taiwan
Study Completion
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 18, 2025
Record last verified: 2025-01
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Source: ClinicalTrials.gov.
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