Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT06333951
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2024-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'C000706028', 'term': 'sotorasib'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-10-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing Dose Limiting Toxicities (DLT)', 'timeFrame': 'Up to approximately 21 days'}, {'measure': 'Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)', 'timeFrame': 'Up to approximately 3 years', 'description': 'TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.'}, {'measure': 'Number of Participants Experiencing Serious Adverse Events (SAE)', 'timeFrame': 'Up to approximately 3 years', 'description': 'An SAE is defined as any AE that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.'}], 'secondaryOutcomes': [{'measure': 'Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Disease Control (DC) per RECIST v1.1', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Duration of Response (DOR) per RECIST v1.1', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Time to Response (TTR) per RECIST v1.1', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Overall Survival (OS) per RECIST v1.1', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Progression-free Survival (PFS) per RECIST v1.1', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Maximum Plasma Concentration (Cmax) of AMG 193', 'timeFrame': 'Up to Day 1 of Cycle 5 (one cycle = 21 days)'}, {'measure': 'Time to Maximum Plasma Concentration (tmax) of AMG 193', 'timeFrame': 'Up to Day 1 of Cycle 5 (one cycle = 21 days)'}, {'measure': 'Area Under the Plasma Concentration-time Curve (AUC) of AMG 193', 'timeFrame': 'Up to Day 1 of Cycle 5 (one cycle = 21 days)'}, {'measure': 'Intracranial objective response (IOR) per Response Assessment in Neuro Oncology Brain Metastases (RANO-BM )', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Intracranial Disease Control (IDC) per RANO-BM', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Intracranial Duration of Response (IDOR) per RANO-BM', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Time to Intracranial Radiation Therapy per RANO-BM', 'timeFrame': 'Up to approximately 3 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oncology', 'Methylthioadenosine phosphorylase', 'AMG 193', 'PRMT5 inhibitor', 'MTAP', 'NSCLC'], 'conditions': ['Thoracic Tumors', 'Non-small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nSubprotocol A, B, and C\n\n* Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).\n* Tumor tissue (formalin-fixed, paraffin-embedded sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before AMG 193 dosing.\n* Homozygous MTAP-deletion\n* Able to swallow and retain PO administered study treatment.\n* Disease measurable as defined by RECIST v1.1.\n\nSubprotocol A - Histologically or cytologically confirmed diagnosis of NSCLC.\n\nArm A (AMG 193 + carboplatin + paclitaxel + pembrolizumab):\n\n\\- Predominantly squamous histology.\n\nArm B (AMG 193 + carboplatin + pemetrexed + pembrolizumab):\n\n\\- Predominantly non-squamous histology.\n\nArm C (AMG 193 + pembrolizumab):\n\n\\- PD-L1 positive.\n\nSubprotocol B - Histologically confirmed NSCLC with homozygous MTAP-deletion and KRAS p.G12C mutation.\n\nSubprotocol C\n\n* Histologically or cytologically confirmed diagnosis of NSCLC with brain metastases.\n* Brain lesion meeting RANO-BM criteria for measurable disease.\n\nExclusion Criteria\n\nSubprotocol A, B, and C\n\n* Cardiovascular and pulmonary exclusion criteria as defined in the protocol.\n* Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).\n* History of solid organ transplant.\n* Major surgery within 28 days of first dose of AMG 193.\n* Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.\n* Radiation therapy within 28 days of first dose.\n\nSubprotocol A\n\n\\- Autoimmune disease or immunodeficiency disease as defined in the protocol'"}, 'identificationModule': {'nctId': 'NCT06333951', 'briefTitle': 'AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)', 'orgStudyIdInfo': {'id': '20230167'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm A', 'description': 'Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 orally (PO) and carboplatin, paclitaxel, and pembrolizumab intravenously (IV)', 'interventionNames': ['Drug: AMG 193', 'Drug: Carboplatin', 'Drug: Paclitaxel', 'Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Subprotocol A: NSCLC Arm B', 'description': 'Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 PO and carboplatin, pemetrexed, and pembrolizumab IV', 'interventionNames': ['Drug: AMG 193', 'Drug: Carboplatin', 'Drug: Pembrolizumab', 'Drug: Pemetrexed']}, {'type': 'EXPERIMENTAL', 'label': 'Subprotocol A: NSCLC Arm C', 'description': 'Participants with MTAP-deleted NSCLC will receive a combination of AMG 193 PO and pembrolizumab IV', 'interventionNames': ['Drug: AMG 193', 'Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Subprotocol B: NSCLC With KRasG12C Mutation', 'description': 'Participants with MTAP-deleted NSCLC and KRasG12C mutation will receive a combination of AMG 193 and sotorasib PO', 'interventionNames': ['Drug: AMG 193', 'Drug: Sotorasib']}, {'type': 'EXPERIMENTAL', 'label': 'Subprotocol C: NSCLC With Brain Metastases', 'description': 'Participants with MTAP-deleted NSCLC with brain metastases will receive AMG 193 PO', 'interventionNames': ['Drug: AMG 193']}], 'interventions': [{'name': 'AMG 193', 'type': 'DRUG', 'description': 'Administered PO', 'armGroupLabels': ['Subprotocol A: NSCLC Arm B', 'Subprotocol A: NSCLC Arm C', 'Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm A', 'Subprotocol B: NSCLC With KRasG12C Mutation', 'Subprotocol C: NSCLC With Brain Metastases']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Subprotocol A: NSCLC Arm B', 'Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm A']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm A']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Subprotocol A: NSCLC Arm B', 'Subprotocol A: NSCLC Arm C', 'Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm A']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Subprotocol A: NSCLC Arm B']}, {'name': 'Sotorasib', 'type': 'DRUG', 'description': 'Administered PO', 'armGroupLabels': ['Subprotocol B: NSCLC With KRasG12C Mutation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Comprehensive Blood and Cancer Center', 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{'zip': '06800', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Bilkent Sehir Hastanesi', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Amgen Call Center', 'role': 'CONTACT', 'email': 'medinfo@amgen.com', 'phone': '866-572-6436'}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': 'http://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of reevaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}