Ignite Creation Date:
2025-12-25 @ 1:37 AM
Ignite Modification Date:
2026-01-25 @ 8:53 AM
Study NCT ID:
NCT06686394
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2024-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000710748', 'term': 'patritumab deruxtecan'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'C000630669', 'term': 'Ogivri'}, {'id': 'C000631275', 'term': 'Ontruzant'}, {'id': 'C485206', 'term': 'pertuzumab'}, {'id': 'C000705452', 'term': 'tucatinib'}], '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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 81}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-04-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2024-11-11', 'studyFirstSubmitQcDate': '2024-11-11', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-04-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing Dose-Limiting Toxicity (DLT)', 'timeFrame': 'Up to 21 days', 'description': 'DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. The number of participants who experience a DLT will be presented.'}, {'measure': 'Number of Participants with One or More Adverse Events (AEs)', 'timeFrame': 'Up to approximately 13 months', 'description': 'An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented.'}, {'measure': 'Number of Participants who Discontinue Study Intervention Due to an AE', 'timeFrame': 'Up to approximately 12 months', 'description': 'An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be presented.'}], 'secondaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan Antibody-Drug Conjugate (ADC)', 'timeFrame': 'At designated time points (up to ~13 months)', 'description': 'Blood samples collected at designated time points will be used to determine the Cmax of patritumab deruxtecan ADC.'}, {'measure': 'Trough Concentration (Ctrough) of Patritumab Deruxtecan ADC', 'timeFrame': 'At designated time points (up to ~13 months)', 'description': 'Blood samples collected at designated time points will be used to determine the Ctrough of patritumab deruxtecan ADC.'}, {'measure': 'Area Under the Plasma Concentration-Time Curve (AUC) of Patritumab Deruxtecan ADC', 'timeFrame': 'At designated time points (up to ~13 months)', 'description': 'Blood samples collected at designated time points will be used to determine the AUC of patritumab deruxtecan ADC.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Total Patritumab Deruxtecan Antidrug Antibody (ADA)', 'timeFrame': 'At designated time points (up to ~13 months)', 'description': 'Blood samples collected at designated time points will be used to determine the Cmax of total patritumab deruxtecan ADA.'}, {'measure': 'Trough Concentration (Ctrough) of Total Patritumab Deruxtecan ADA', 'timeFrame': 'At designated time points (up to ~13 months)', 'description': 'Blood samples collected at designated time points will be used to determine the Ctrough of total patritumab deruxtecan ADA.'}, {'measure': 'Area Under the Plasma Concentration-Time Curve (AUC) of Total Patritumab Deruxtecan ADA', 'timeFrame': 'At designated time points (up to ~13 months)', 'description': 'Blood samples collected at designated time points will be used to determine the AUC of total patritumab deruxtecan ADA.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan Free Payload', 'timeFrame': 'At designated time points (up to ~13 months)', 'description': 'Blood samples collected at designated time points will be used to determine the Cmax of patritumab deruxtecan free payload.'}, {'measure': 'Trough Concentration (Ctrough) of Patritumab Deruxtecan Free Payload', 'timeFrame': 'At designated time points (up to ~13 months)', 'description': 'Blood samples collected at designated time points will be used to determine the Ctrough of patritumab deruxtecan free payload.'}, {'measure': 'Area Under the Plasma Concentration-Time Curve (AUC) of Patritumab Deruxtecan Free Payload', 'timeFrame': 'At designated time points (up to ~13 months)', 'description': 'Blood samples collected at designated time points will be used to determine the AUC of patritumab deruxtecan free payload.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Neoplasms', 'Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn:\n\n* About the safety and how well people tolerate of patritumab deruxtecan\n* How many people have the cancer respond (get smaller or go away) to treatment', 'detailedDescription': 'The following countries will be participating in the trial: Canada, United Kingdom, Israel, Japan, South Korea, and USA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer\n* Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load before allocation\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention\n\nArm 1:\n\n* Has received at least a minimum of 2 and a maximum of 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting\n* Had disease progression on or after any previous trastuzumab deruxtecan (T-DXd) treatment\n\nArm 2:\n\n-Has received no more than 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting\n\nArm 3:\n\n-Has received and had disease progression from T-DXd treatment in any setting and a maximum of 3 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting. T-DXd must be the most recent therapy received before enrollment.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Uncontrolled or significant cardiovascular disease\n* History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/interstitial lung disease\n* Has clinically severe respiratory compromise\n* Has any history of or evidence of any current leptomeningeal disease\n* Has clinically significant corneal disease\n* Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection\n* HIV infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Evidence of spinal cord compression or brain metastases\n* Has an active infection requiring systemic therapy\n* Concurrent active HBV and HCV infection\n* Has had major surgical procedure (excluding placement of vascular access) less than 28 days\n\nArm 3 ONLY\n\n\\- Has received prior treatment with tucatinib, lapatinib, or neratinib, or any investigational HER2-targeted tyrosine kinase inhibitors in the locally advanced or metastatic setting"}, 'identificationModule': {'nctId': 'NCT06686394', 'briefTitle': 'Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': '1022-009'}, 'secondaryIdInfos': [{'id': 'MK-1022-009', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'jRCT2041250022', 'type': 'REGISTRY', 'domain': 'Japan Registry of Clinical Trials (jRCT)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patritumab deruxtecan plus trastuzumab', 'description': 'Participants receive patritumab deruxtecan intravenous (IV) infusion and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.', 'interventionNames': ['Biological: Patritumab deruxtecan', 'Biological: Trastuzumab', 'Biological: Trastuzumab Biosimilar']}, {'type': 'EXPERIMENTAL', 'label': 'Patritumab deruxtecan plus pertuzumab and trastuzumab', 'description': 'Participants receive patritumab deruxtecan IV infusion, pertuzumab IV infusion, and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.', 'interventionNames': ['Biological: Patritumab deruxtecan', 'Biological: Trastuzumab', 'Biological: Trastuzumab Biosimilar', 'Biological: Pertuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'Patritumab deruxtecan plus trastuzumab and tucatinib', 'description': 'Participants receive patritumab deruxtecan IV infusion and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks), and tucatinib is administered orally twice daily for each 21-day cycle, until disease progression, intolerable toxicity, or investigator decision.', 'interventionNames': ['Biological: Patritumab deruxtecan', 'Biological: Trastuzumab', 'Biological: Trastuzumab Biosimilar', 'Biological: Tucatinib']}], 'interventions': [{'name': 'Patritumab deruxtecan', 'type': 'BIOLOGICAL', 'otherNames': ['MK-1022', 'HER3-DXd', 'U3-1402'], 'description': 'Patritumab deruxtecan administered via IV infusion', 'armGroupLabels': ['Patritumab deruxtecan plus pertuzumab and trastuzumab', 'Patritumab deruxtecan plus trastuzumab', 'Patritumab deruxtecan plus trastuzumab and tucatinib']}, {'name': 'Trastuzumab', 'type': 'BIOLOGICAL', 'otherNames': ['Herceptin®'], 'description': 'Trastuzumab administered via IV infusion', 'armGroupLabels': ['Patritumab deruxtecan plus pertuzumab and trastuzumab', 'Patritumab deruxtecan plus trastuzumab', 'Patritumab deruxtecan plus trastuzumab and tucatinib']}, {'name': 'Trastuzumab Biosimilar', 'type': 'BIOLOGICAL', 'otherNames': ['Trazimera®', 'Ogivri®', 'Herzuma®', 'Ontruzant®', 'Kanjinti®', 'Hercessi®'], 'description': 'Trastuzumab biosimilar administered via IV infusion', 'armGroupLabels': ['Patritumab deruxtecan plus pertuzumab and trastuzumab', 'Patritumab deruxtecan plus trastuzumab', 'Patritumab deruxtecan plus trastuzumab and tucatinib']}, {'name': 'Pertuzumab', 'type': 'BIOLOGICAL', 'description': 'Pertuzumab administered via IV infusion', 'armGroupLabels': ['Patritumab deruxtecan plus pertuzumab and trastuzumab']}, {'name': 'Tucatinib', 'type': 'BIOLOGICAL', 'description': 'Tucatinib administered as oral tablets', 'armGroupLabels': ['Patritumab deruxtecan plus trastuzumab and tucatinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '877-338-7425'}], 'facility': 'Dana-Farber Cancer Institute ( Site 0050)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '732-235-2465'}], 'facility': 'Rutgers Cancer Institute of New Jersey ( Site 0052)', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '864-455-3600'}], 'facility': 'Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053)', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '571-472-4724'}], 'facility': 'Inova Schar Cancer Institute ( Site 0051)', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '6135336541'}], 'facility': 'Kingston General Hospital ( Site 0061)', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '416-946-4501'}], 'facility': 'Princess Margaret Cancer Centre ( Site 0001)', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X 3E4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '(514)890-8000 x20737'}], 'facility': "Centre Hospitalier de l'Université de Montréal ( Site 0004)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '514-340-8222'}], 'facility': 'Jewish General Hospital ( Site 0003)', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '3109601', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '04-7776234'}], 'facility': 'Rambam Health Care Campus ( Site 0011)', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '4941492', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+972-505533121'}], 'facility': 'Rabin Medical Center ( Site 0012)', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '5265601', 'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '03-5304498'}], 'facility': 'Sheba Medical Center ( Site 0010)', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '467-8602', 'city': 'Nagoya', 'state': 'Aichi-ken', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-52-851-5511'}], 'facility': 'Nagoya City University Hospital ( Site 0020)', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '82-2-2072-0850'}], 'facility': 'Seoul National University Hospital ( Site 0030)', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+82-2-1688-7575'}], 'facility': 'Asan Medical Center ( Site 0031)', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': 'NW1 2PG', 'city': 'London', 'state': 'Camden', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+442034472930'}], 'facility': 'University College London Hospital ( Site 0041)', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'EC1A 7BE', 'city': 'London', 'state': 'London, City of', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+442073777000'}], 'facility': 'St Bartholomew s Hospital ( Site 0040)', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Toll Free Number', 'role': 'CONTACT', 'email': 'Trialsites@msd.com', 'phone': '1-888-577-8839'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://externaldatasharing-msd.com/', 'ipdSharing': 'YES', 'description': 'https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}