A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC
NCT Number: NCT06478693
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hepatocellular Carcinoma
Interventions: DRUG: MT-303
Sponsor: Myeloid Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-05-31
Locations: St 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|Linear Clinical Research, Murdoch, Western Australia, 6150, Australia

Summary:
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 in participants with advanced hepatocellular carcinoma expressing GPC3.

Primary Outcome Measures: 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|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|Change from baseline in ECG parameters, Screening, Day 1 and Day 15
Secondary Outcome Measures: To assess the pharmacokinetics (PK) of MT-303, PK parameter: Plasma concentrations, Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP|To assess the pharmacokinetics (PK) of MT-303, PK parameter: Area under Curve, Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP|To assess the pharmacokinetics (PK) of MT-303, PK parameter: Time of maximum observed plasma concentration (tmax), Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP|To assess the pharmacokinetics (PK) of MT-303, PK parameter: Plasma Clearance (CL), Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP|To assess the pharmacokinetics (PK) of MT-303, PK parameter: Volume of Distribution (Vd), Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP|To assess the pharmacokinetics (PK) of MT-303, PK parameter: Mean residence time (MRT), Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP|To assess the pharmacokinetics (PK) of MT-303, PK parameter: terminal rate constant (λz), Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP|To assess adverse events of special interest (AESI) by measuring infusion reaction, upto 2 years from the last dose of IMP|To assess adverse events of special interest (AESI) by measuring cytokine release syndrome (CRS), Up to 2 years from the last dose of IMP|To assess adverse events of special interest (AESI) by measuring immune effector cell-associated neurotoxicity syndrome (ICANS), Up to 2 years from the last dose of IMP|To assess adverse events of special interest (AESI) by measuring hypersensitivity reaction, Up to 2 years from the last dose of IMP|To assess adverse events of special interest (AESI) by checking for second primary malignancy, upto 2 years from the last dose of IMP