Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-03 @ 4:12 PM
Study NCT ID:
NCT04123418
Status:
TERMINATED
Last Update Posted:
2025-12-24
First Post:
2019-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of WVT078 in Patients With Multiple Myeloma (MM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'whyStopped': 'The decision was made for business reasons and was not based on any safety or tolerability concerns', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2019-10-02', 'studyFirstSubmitQcDate': '2019-10-09', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose limiting toxicity (DLTs) in Cycle 1', 'timeFrame': '28 days (first cycle)', 'description': 'To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM'}, {'measure': 'Frequency of dose interruptions', 'timeFrame': 'Up to 28 months', 'description': 'To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM'}, {'measure': 'Frequency of discontinuations', 'timeFrame': 'up to 28 months', 'description': 'To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM'}, {'measure': 'Frequency of dose reductions', 'timeFrame': 'up to 28 months', 'description': 'To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM'}, {'measure': 'Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, ECGs, and CRS/immune-mediated reactions', 'timeFrame': 'Up to 31 months', 'description': 'To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM'}], 'secondaryOutcomes': [{'measure': 'Best Overall Response (BOR)', 'timeFrame': 'Up to 36 months', 'description': 'Response assessment per International Myeloma Working Group (IMWG) criteria'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to 36 months', 'description': 'Response assessment per International Myeloma Working Group (IMWG) criteria'}, {'measure': 'Progresson Free Survival (PFS)', 'timeFrame': 'Up to 36 months', 'description': 'Response assessment per International Myeloma Working Group (IMWG) criteria'}, {'measure': 'AUC of WVT078 derived from serum concentrations', 'timeFrame': 'Up to 28 months'}, {'measure': 'Cmax of WVT078 derived from serum concentrations', 'timeFrame': 'Up to 28 months'}, {'measure': 'Cmin of WVT078 derived from serum concentrations', 'timeFrame': 'Up to 28 months'}, {'measure': 'Tmax of WVT078 derived from serum concentrations', 'timeFrame': 'Up to 28 months'}, {'measure': 'T1/2 of WVT078 derived from serum concentrations', 'timeFrame': 'Up to 28 months'}, {'measure': 'Concentration of WVT078 Anti Drug Antibodies (ADA) as measured in serum', 'timeFrame': 'Up to 28 months'}, {'measure': 'AUC of WHG626 derived from plasma concentrations', 'timeFrame': 'Up to 28 months'}, {'measure': 'Cmax of WHG626 derived from plasma concentrations', 'timeFrame': 'Up to 28 months'}, {'measure': 'Cmin of WHG626 derived from plasma concentrations', 'timeFrame': 'Up to 28 months'}, {'measure': 'Tmax of WHG626 derived from plasma concentrations', 'timeFrame': 'Up to 28 months'}, {'measure': 'T1/2 of WHG626 derived from plasma concentrations', 'timeFrame': 'Up to 28 months'}, {'measure': 'AUC of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations', 'timeFrame': 'Up to 28 months'}, {'measure': 'Cmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations', 'timeFrame': 'Up to 28 months'}, {'measure': 'Cmin of GWQ573 (the active metabolite of WHG626) devived from plasma concentrations', 'timeFrame': 'Up to 28 months'}, {'measure': 'Tmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations', 'timeFrame': 'Up to 28 months'}, {'measure': 'T1/2 of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations', 'timeFrame': 'Up to 28 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma, phase 1'], 'conditions': ['Multiple Myeloma (MM)']}, 'referencesModule': {'references': [{'pmid': '37024520', 'type': 'DERIVED', 'citation': 'Raab MS, Cohen YC, Schjesvold F, Aardalen K, Oka A, Spencer A, Wermke M, Souza AD, Kaufman JL, Cafro AM, Ocio EM, Doki N, Henson K, Trabucco G, Carrion A, Bender FC, Juif PE, Fessehatsion A, Fan L, Stonehouse JP, Blankenship JW, Granda B, De Vita S, Lu H. Preclinical discovery and initial clinical data of WVT078, a BCMA x CD3 bispecific antibody. Leukemia. 2023 Jun;37(6):1349-1360. doi: 10.1038/s41375-023-01883-3. Epub 2023 Apr 6.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18365', 'label': 'CWVT078A12101 Clinical Trial Results Form'}, {'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=3005', 'label': 'A Plain Language Trial Summary is available on www.novctrd.com'}]}, 'descriptionModule': {'briefSummary': 'The design of a phase I, open-label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent WVT078 alone and in combination with WHG626 in patients relapses and/or refractory Multiple Myeloma (MM)', 'detailedDescription': 'This first-in-human trial with WVT078 is a dose escalation study whose primary purpose is to characterize the safety, tolerability, and determine recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with MM who have received two or more standard of care lines of therapy including an IMID, a proteasome inhibitor, and an anti-CD38 agent (if available) and are relapsed and/or refractory to or intolerant of each regimen. In addition, this study will assess preliminary anti-MM response of and characterize the pharmacokinetics and immunogenicity of WVT078 alone and in combination with WHG626. The results of this study will inform the future development of WVT078 alone and in combination with WHG626 as a treatment for relapsed and/or refractory MM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who are relapsed and/or refractory to two or more regimens including an IMID, proteasome inhibitor, and an anti-CD38 agent (if available)\n\nExclusion Criteria:\n\n* Use of systemic chronic steroid therapy (\\>or= 10mg/day prednisone or equivalent) or any immunosuppressive therapy within 7 days of first dose of study treatment\n* Malignant disease other than being treated on this study\n* Active known or suspected autoimmune disease\n* Impaired cardiac function or clinically significant cardiac disease\n* Treatment with cytotoxic or small molecule antineoplastics or any experimental therapy within 14 days or 5 half-lives whichever is shorter\n* Active central nervous system involvement by malignancy or presence of symptomatic CNS metasteses'}, 'identificationModule': {'nctId': 'NCT04123418', 'briefTitle': 'A Study of WVT078 in Patients With Multiple Myeloma (MM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase I, Open-label, Multicenter, Study of WVT078 in Subjects With Relapsed and/or Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'CWVT078A12101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WVT078 in Multiple Myeloma (MM) patients', 'description': 'Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)', 'interventionNames': ['Biological: WVT078']}, {'type': 'EXPERIMENTAL', 'label': 'WVT078 in combination with WHG626 in Multiple Myeloma (MM) patients', 'description': 'Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)', 'interventionNames': ['Biological: WVT078', 'Drug: WHG626']}], 'interventions': [{'name': 'WVT078', 'type': 'BIOLOGICAL', 'description': 'WVT078 will be administered IV (intravenously) in a dose escalation schedule', 'armGroupLabels': ['WVT078 in Multiple Myeloma (MM) patients', 'WVT078 in combination with WHG626 in Multiple Myeloma (MM) patients']}, {'name': 'WHG626', 'type': 'DRUG', 'description': 'WHG626 will be administered orally in a dose escalation schedule', 'armGroupLabels': ['WVT078 in combination with WHG626 in Multiple Myeloma (MM) patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine-Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University Of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '6423906', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '20162', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '113-8677', 'city': 'Bunkyo Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': 'NO-0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}