Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2026-01-26 @ 3:08 AM
Study NCT ID:
NCT06478693
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2024-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'C537340', 'term': 'Simpson-Golabi-Behmel syndrome'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2024-06-24', 'studyFirstSubmitQcDate': '2024-06-24', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type, incidence and severity of Adverse Events', 'timeFrame': 'Up to 2 years from the last dose of Investigational Medicinal Product (IMP)', 'description': 'Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0'}, {'measure': 'Recommended Phase 2 Dose (RP2D)', 'timeFrame': '28 days from the last dose of IMP', 'description': 'The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data'}, {'measure': 'Optimal Biological dose (OBD)', 'timeFrame': '21 days from the last dose of IMP', 'description': 'The OBD will be determined using dose limiting toxicities (DLTs) and all other available study data'}, {'measure': 'Change from baseline in vital signs', 'timeFrame': 'Up to 30 days from the last dose of IMP', 'description': 'Temperature, weight, height, pulse rate and blood pressure will be assessed'}, {'measure': 'Change in laboratory parameters', 'timeFrame': 'Up to 30 days from the last dose of IMP', 'description': 'Hematology, chemistry, coagulation, virology and urine analysis will be assessed.'}, {'measure': 'Change from baseline in ECG parameters', 'timeFrame': 'Screening, Day 1 and Day 15'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK)', 'timeFrame': '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.', 'description': 'PK parameter: Plasma concentrations'}, {'measure': 'Pharmacokinetics (PK)', 'timeFrame': '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.', 'description': 'PK parameter: Area under Curve'}, {'measure': 'Pharmacokinetics (PK)', 'timeFrame': '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.', 'description': 'PK parameter: Time of maximum observed plasma concentration (tmax)'}, {'measure': 'Pharmacokinetics (PK)', 'timeFrame': '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.', 'description': 'PK parameter: Plasma Clearance (CL)'}, {'measure': 'Pharmacokinetics (PK)', 'timeFrame': '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.', 'description': 'PK parameter: Volume of Distribution (Vd)'}, {'measure': 'Pharmacokinetics (PK)', 'timeFrame': '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.', 'description': 'PK parameter: Mean residence time (MRT)'}, {'measure': 'Pharmacokinetics (PK)', 'timeFrame': '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.', 'description': 'PK parameter: terminal rate constant (λz)'}, {'measure': 'To assess adverse events of special interest (AESI) by measuring infusion reaction', 'timeFrame': 'upto 2 years from the last dose of IMP'}, {'measure': 'To assess adverse events of special interest (AESI) by measuring cytokine release syndrome (CRS)', 'timeFrame': 'Up to 2 years from the last dose of IMP'}, {'measure': 'To assess adverse events of special interest (AESI) by measuring immune effector cell-associated neurotoxicity syndrome (ICANS)', 'timeFrame': 'Up to 2 years from the last dose of IMP'}, {'measure': 'To assess adverse events of special interest (AESI) by measuring hypersensitivity reaction', 'timeFrame': 'Up to 2 years from the last dose of IMP'}, {'measure': 'To assess adverse events of special interest (AESI) by checking for second primary malignancy', 'timeFrame': 'upto 2 years from the last dose of IMP'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver Cancer', 'Hepatocellular Carcinoma (HCC)', 'Glypican-3', 'Chimeric antigen receptor', 'CAR-M'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Participants will be enrolled into one of two treatment modules:\n\n* Module 1 (Monotherapy): Participants will receive MT-303.\n* Module 2 (Combination therapy): Participants will receive MT-303 in combination with atezolizumab + bevacizumab (Atezo/Bev).\n\nIn 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.\n\nAdditional cohorts in both modules may be scheduled based on emerging safety and PK data.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Aged 18 years or older\n* Histological diagnosis of advanced/recurrent or metastatic and/or unresectable HCC. \\[Note: participants with other tumor types expressing GPC3 may be eligible for Module 1 pending a discussion with the Medical Monitor. Only participants with HCC are eligible for Module 2.\n* Measurable lesion per RECIST 1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1\n* Child-Pugh score: Class A\n* Adequate organ function\n\nGeneral Exclusion Criteria\n\n* Known active CNS metastasis and/or carcinomatous meningitis.\n* Any acute illness including active infection\n* History of liver transplantation or on waiting list\n* Participants with untreated or incompletely treated varices with bleeding or high risk for bleeding\n* Uncontrolled pleural effusion, pericardial effusion, or ascites\n* History of symptomatic congestive heart failure\n* History of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immune-suppressive treatments.\n\nAdditional Module 2 Exclusion Criteria:\n\n* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n* Significant cardiovascular disease\n* History of severe hypersensitivity to atezolizumab and/or bevacizumab.\n* History of idiopathic pulmonary fibrosis\n* Prior history of hypertensive crisis or hypertensive encephalopathy.'}, 'identificationModule': {'nctId': 'NCT06478693', 'briefTitle': 'A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Myeloid Therapeutics'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MTX-GPC3-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MT-303', 'description': 'Participants will receive MT-303 through intravenous infusion.', 'interventionNames': ['Drug: MT-303']}, {'type': 'EXPERIMENTAL', 'label': 'MT-303 + Atezolizumab + Bevacizumab', 'description': 'Participants will receive MT-303 in combination with Atezo/Bev through intravenous infusion.', 'interventionNames': ['Drug: MT-303 +Atezolizumab + Bevacizumab']}], 'interventions': [{'name': 'MT-303', 'type': 'DRUG', 'description': 'MT-303', 'armGroupLabels': ['MT-303']}, {'name': 'MT-303 +Atezolizumab + Bevacizumab', 'type': 'DRUG', 'description': 'MT-303 in combination with Atezo/Bev', 'armGroupLabels': ['MT-303 + Atezolizumab + Bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Hao-Wen Sim, MD', 'role': 'CONTACT'}], 'facility': "St Vincent's Hospital", 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Vladimir Andelkovic, MD', 'role': 'CONTACT'}], 'facility': 'Integrated Clinical Oncology Network (ICON) Pty Ltd', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Stuart Roberts, MD', 'role': 'CONTACT'}], 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6150', 'city': 'Murdoch', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Tim Humphries, MD', 'role': 'CONTACT'}], 'facility': 'Linear Clinical Research', 'geoPoint': {'lat': -32.06987, 'lon': 115.83757}}, {'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jeong Heo, MD', 'role': 'CONTACT'}], 'facility': 'Pusan National Univesity Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hongjae Jeoon, MD', 'role': 'CONTACT'}], 'facility': 'Cha University Bundang Medical Center', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yoon Jun Kim, MD', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chih-hung Hsu', 'role': 'CONTACT'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Her-shyong Shiah', 'role': 'CONTACT'}], 'facility': 'Taipei Tzu Chi Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Project Manager', 'role': 'CONTACT', 'email': 'Lucy.FrereScott@novotech-cro.com', 'phone': '+61 2 8569 1400'}, {'name': 'Clinical Department', 'role': 'CONTACT', 'email': '303clinical@myeloidtx.com', 'phone': '+1 617 465 1022'}], 'overallOfficials': [{'name': 'Matthew Maurer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Myeloid Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Myeloid Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CREATE Medicines', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}