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| Name | Class |
|---|---|
| CREATE Medicines | UNKNOWN |
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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.
Participants will be enrolled into one of two treatment modules:
In Module 1 (Monotherapy), participants will receive MT-303 across five dose-escalation cohorts and in Module 2 (Combination therapy), participants will receive MT-303 in combination with Atezo/Bev across five dose-escalation cohorts.
Additional cohorts in both modules may be scheduled based on emerging safety and PK data.
Participants will be sequentially enrolled into Cohorts 1 through 5. Both modules will be enrolled concurrently, with Module 2 dosing beginning at one dose level below the known safe dose in Module 1. Safety Review Committee decisions will be informed by all available safety data from Modules 1 and 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-303 | Experimental | Participants will receive MT-303 through intravenous infusion. |
|
| MT-303 + Atezolizumab + Bevacizumab | Experimental | Participants will receive MT-303 in combination with Atezo/Bev through intravenous infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-303 | Drug | MT-303 |
| |
| MT-303 +Atezolizumab + Bevacizumab |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change from baseline in ECG parameters | Screening, Day 1 and Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) | PK parameter: Plasma concentrations | 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) |
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Inclusion Criteria
General Exclusion Criteria
Additional Module 2 Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Project Manager | Contact | +61 2 8569 1400 | Lucy.FrereScott@novotech-cro.com | |
| Clinical Department | Contact | +1 617 465 1022 | 303clinical@myeloidtx.com |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Maurer, MD | Myeloid Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent's Hospital | Recruiting | Sydney | New South Wales | 2010 | Australia |
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| Drug |
MT-303 in combination with Atezo/Bev |
|
PK parameter: Area under Curve
| 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) | 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 for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2. |
| Pharmacokinetics (PK) | PK parameter: Plasma Clearance (CL) | 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) | PK parameter: Volume of Distribution (Vd) | 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) | PK parameter: Mean residence time (MRT) | 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) | PK parameter: terminal rate constant (λz) | 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. |
| 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 |
| Integrated Clinical Oncology Network (ICON) Pty Ltd | Recruiting | Woolloongabba | Queensland | 4102 | Australia |
|
| The Alfred Hospital | Recruiting | Melbourne | Victoria | 3004 | Australia |
|
| Linear Clinical Research | Recruiting | Murdoch | Western Australia | 6150 | Australia |
|
| Pusan National Univesity Hospital | Recruiting | Busan | South Korea |
|
| Cha University Bundang Medical Center | Recruiting | Gyeonggi-do | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
|
| Taipei Tzu Chi Hospital | Recruiting | Taipei | Taiwan |
|
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| C537340 | Simpson-Golabi-Behmel syndrome |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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