Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT04829604
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-14
First Post:
2021-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000710874', 'term': 'ARX788'}, {'id': 'D018796', 'term': 'Immunoconjugates'}], 'ancestors': [{'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D007155', 'term': 'Immunologic Factors'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'One single arm, open label with intravenous infusion of ARX788 to assess the anticancer activity and safety of ARX788 in subjects with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive (HER2+) breast cancer.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 71}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2021-03-18', 'studyFirstSubmitQcDate': '2021-04-01', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluate Biomarker', 'timeFrame': '2 years', 'description': 'To evaluate exploratory blood- and tissue-based biomarkers related to study drug response'}], 'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': '2 years', 'description': 'To evaluate the confirmed objective response rate (ORR) as determined by Investigator assessment based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) following treatment with ARX788.\n\nThe ORR is defined as the number of subjects with a BOR of CR or PR divided by the number of response evaluable subjects.'}], 'secondaryOutcomes': [{'measure': 'Duration of response (DOR)', 'timeFrame': '2 years', 'description': 'DOR is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first, will be computed for subjects with a BOR of CR or PR.'}, {'measure': 'Best overall response (BOR)', 'timeFrame': '2 years', 'description': 'BOR is defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started)'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': '2 years', 'description': 'DCR is defined as the proportion of complete response (CR), partial response (PR), and stable disease (SD) rates.'}, {'measure': 'Overall survival (OS)', 'timeFrame': '2.5 years', 'description': 'Overall survival (OS) is defined as the time from first dose of study therapy to the date of death (any cause). Subjects who are alive will be censored at the last known time that the subject was alive.'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': '2 years', 'description': 'PFS is defined as the time between date of first dose of study therapy and date of progression or death, whichever occurs first, will be computed for response evaluable subjects. Subjects will be censored at time of subsequent therapy'}, {'measure': 'The number of subjects experiencing adverse event TEAEs', 'timeFrame': '2 years', 'description': 'Patient safety and adverse events (AEs) will be evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. All AEs and serious adverse events (SAEs) will be assessed to determine the safety and tolerability of the treatment.'}, {'measure': 'Maximum serum concentration (Cmax) for ARX788', 'timeFrame': 'Cycle 1 and cycle 3', 'description': 'Pharmacokinetic parameter maximum serum concentration (Cmax) for ARX788, ADC, ADA, total antibody, and pAF-AS269'}, {'measure': 'Trough concentration (Ctrough) for ARX788', 'timeFrame': 'Cycle 1 and cycle 3', 'description': 'Pharmacokinetic parameter trough concentration (Ctrough) for ARX788, ADC, total antibody, and pAF-AS269'}, {'measure': 'Area under the serum concentration-time curve (AUC) for ARX788', 'timeFrame': 'Cycle 1 and cycle 3', 'description': 'Pharmacokinetic parameter area under the serum concentration-time curve (AUC) for ARX788, ADC, total antibody, and pAF-AS269'}, {'measure': 'Time to response (TTR)', 'timeFrame': 'Start of treatment to first objective confirmed BOR of CR or PR, assessed for approximately 2 years', 'description': 'Time it takes for patient to respond to study treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HER2-postive', 'Breast cancer', 'Antibody drug', 'Metastatic', 'ARX788', 'HER2'], 'conditions': ['HER2 Positive Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd', 'detailedDescription': 'A Global, Single Arm, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Age ≥ 18 years and older\n* Life expectancy ≥ 6 months\n* Unresectable or metastatic breast cancer subjects\n* Presence of at least one measurable lesion per RECIST v 1.1\n* Subjects must have HER2 positive breast cancer per ASCO-CAP guidelines, documented in a CLIA lab pathology report\n* Subjects must have had prior treatment with no more than 5 prior regimens of systemic treatment HER-2 targeting therapy or chemotherapy in the metastatic setting. One of these prior treatments must have been treatment with T-DXd.\n* Subjects with stable brain metastases\n* Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade ≤1 as per the NCI-CTCAE v 5.0, except alopecia, vitiligo, Grade 2 peripheral neuropathy, or endocrine toxicities that are stable on hormone replacement.\n* Adequate organ functions\n* Willing and able to understand and sign an informed consent inform and to comply with all aspects of the protocol\n\nKey Exclusion Criteria:\n\nAny subject who meets any of the following criteria is excluded from the study:\n\n* History of allergic reactions to any component of ARX788.\n* Prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease. Any requirement for supplemental oxygen.\n* Any active ocular infections or chronic corneal disorders\n* History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, cardiac arrhythmia, or myocardial infarction within 6 months prior to enrollment\n* Grade 3 to 4 peripheral neuropathy (NCI CTCAE v 5.0).\n* History of unstable central nervous system (CNS) metastases\n* Radiotherapy outside of the brain administered \\< 7 days prior to first dose of ARX788\n* Current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic diseases)\n* Any uncontrollable intercurrent illness, infection (including subjects with active, symptomatic Covid-19 infections), or other conditions that could limit study compliance or interfere with assessments\n* Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of ARX788'}, 'identificationModule': {'nctId': 'NCT04829604', 'briefTitle': 'ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ambrx, Inc.'}, 'officialTitle': 'A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd', 'orgStudyIdInfo': {'id': 'ACE-Breast-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARX788', 'description': 'The investigational medicinal product (IMP), ARX788, will be administered every 3 weeks (Q3W) by intravenous (IV) infusion.', 'interventionNames': ['Drug: ARX788']}], 'interventions': [{'name': 'ARX788', 'type': 'DRUG', 'otherNames': ['antibody drug conjugate (ADC)'], 'description': 'The active pharmaceutical ingredient in ARX788 is an antibody drug conjugate (ADC) consisting of a humanized anti-HER2 monoclonal antibody (mAb) (IgG1κ) covalently conjugated to two microtubule-disrupting payloads AS269', 'armGroupLabels': ['ARX788']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90602', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '30607', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 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