Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT02375958
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2015-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PCA062 in pCAD-positive Tumors.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'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': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-16', 'studyFirstSubmitDate': '2015-02-09', 'studyFirstSubmitQcDate': '2015-02-24', 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence rate of dose limiting toxicities', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Incidence and severity of serious/adverse events', 'timeFrame': 'Duration of study (each treatment cycle = 14 days)'}, {'measure': 'Pharmacokinetic parameter Cmax', 'timeFrame': '84 days', 'description': 'Cmax = the maximum concentration (peak) of the drug observed in the blood after a single administration of the drug'}, {'measure': 'Presence of PCA062 anti-bodies', 'timeFrame': '84 days', 'description': 'The presence and/or concentration of the anti-bodies will be tested from the blood samples collected'}, {'measure': 'Overall response rate', 'timeFrame': 'Duration of study (each treatment cycle = 14 days)'}, {'measure': 'Duration of response', 'timeFrame': 'Duration of study (each treatment cycle = 14 days)'}, {'measure': 'Progression free survival', 'timeFrame': '18 months'}, {'measure': 'Disease control rate', 'timeFrame': '18 months'}, {'measure': 'Best overall response', 'timeFrame': 'Duration of study (each treatment cycle = 14 days)'}, {'measure': 'Pharmacokinetic paramater Tmax', 'timeFrame': '84 days', 'description': 'Tmax = the time the drug takes to reach maximum (peak) concentration in the blood'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PCA062', 'Triple Negative Breast Cancer', 'Head & Neck Cancer', 'Esophageal Cancer', 'pCAD, pcadherin, solid-tumors'], 'conditions': ['Triple Negative Breast Cancer', 'Head & Neck Cancer', 'Esophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '35131875', 'type': 'DERIVED', 'citation': "Duca M, Lim DW, Subbiah V, Takahashi S, Sarantopoulos J, Varga A, D'Alessio JA, Abrams T, Sheng Q, Tan EY, Rosa MS, Gonzalez-Maffe J, Sand-Dejmek J, Fabre C, Martin M. A First-in-Human, Phase I, Multicenter, Open-Label, Dose-Escalation Study of PCA062: An Antibody-Drug Conjugate Targeting P-Cadherin, in Patients With Solid Tumors. Mol Cancer Ther. 2022 Apr 1;21(4):625-634. doi: 10.1158/1535-7163.MCT-21-0652."}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17441', 'label': 'Results for CPCA062X2101 can be found on the Novartis Clinical Trial Results Website'}]}, 'descriptionModule': {'briefSummary': 'A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Male or female ≥ 18 years of age\n2. Documented pCAD expressing tumor cells with the exception of HNSCC and ESCC. An archived tumor sample collected within 36 months prior to baseline if available, or a new tumor biopsy sample must be available for molecular pre-screening.\n3. Consent for a tumor biopsy at screening\n4. Progressive disease and no effective therapy exists\n5. Measurable disease as per RECIST v1.1 criteria\n6. ECOG Performance status of ≤ 2\n\nExclusion criteria:\n\n1. CNS metastatic involvement\n2. Clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.\n3. A history of serious allergic reactions, which in the opinion of the investigator pose an increased risk of serious infusion reactions.\n4. Monocular vision or has media opacities or any other condition that precludes monitoring of the retina or the fundus, or has a history of ophthalmology exam with retina or cornea abnormalities\n5. Previously treated with anti-pCAD biologic therapies.\n6. Received anti-cancer therapies within the following time frames prior to the first dose of study treatment:\n\n * Conventional cytotoxic chemotherapy: ≤4 weeks\n * Biologic therapy (eg, antibodies), other than ADCs: ≤4 weeks\n * Non-cytotoxic small molecule therapeutics: ≤5 T1/2 or ≤2 weeks (whichever is longer)\n * Other investigational agents: ≤4 weeks\n * Radiation therapy (palliative setting is allowed.): ≤4 weeks\n * Major surgery: ≤2 weeks\n7. Patient has out of range laboratory values defined as:\n\n * Hematological values:\n * Absolute neutrophil count (ANC) \\<1.5 x 109/L\n * Hemoglobin (Hgb) \\<9 g/dL\n * Platelets \\<100 x 109/L\n * Hepatic and renal function\n * Total bilirubin \\>1.5 x upper limit of normal (ULN). For patients with Gilbert's syndrome, total bilirubin \\>2.5 x ULN.\n * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>3 x ULN for patients without tumor involvement of the liver or \\>5 x ULN for patients with tumor involvement of the liver.\n * Serum creatinine \\>1.5 x ULN and/or measured creatinine clearance \\< 40 ml/min"}, 'identificationModule': {'nctId': 'NCT02375958', 'briefTitle': 'PCA062 in pCAD-positive Tumors.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase 1 Multi-center, Open-label Dose Escalation and Expansion Study of PCA062 Administered Intravenously in Adult Patients With p-CAD Positive Tumors', 'orgStudyIdInfo': {'id': 'CPCA062X2101'}, 'secondaryIdInfos': [{'id': '2014-003732-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Triple Negative Breast Cancer', 'interventionNames': ['Drug: PCA062']}, {'type': 'EXPERIMENTAL', 'label': 'Head and Neck Cancer', 'interventionNames': ['Drug: PCA062']}, {'type': 'EXPERIMENTAL', 'label': 'Esophageal Cancer', 'interventionNames': ['Drug: PCA062']}], 'interventions': [{'name': 'PCA062', 'type': 'DRUG', 'armGroupLabels': ['Esophageal Cancer', 'Head and Neck Cancer', 'Triple Negative Breast Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '20133', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '135 8550', 'city': 'Koto Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '169610', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '28009', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}