Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-30 @ 5:39 PM
Study NCT ID:
NCT05808634
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2023-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 168}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2023-03-17', 'studyFirstSubmitQcDate': '2023-04-10', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Assess dose limiting toxicity as defined in the protocol', 'timeFrame': 'Up to 24 months', 'description': 'Phase 1 Part 1: Safety Profile of BA3182'}, {'measure': 'Part 1: Assess maximum tolerated dose as defined in the protocol', 'timeFrame': 'Up to 24 months', 'description': 'Phase 1 Part 1: Safety Profile of BA3182'}, {'measure': 'Part 2: Confirmed overall response rate (ORR) per RECIST v1.1', 'timeFrame': 'Up to 24 months', 'description': 'Phase 1 Part 2: Antitumor activity of BA3182'}], 'secondaryOutcomes': [{'measure': 'Confirmed overall response rate (ORR) per RECIST v1.1', 'timeFrame': 'Up to 24 months', 'description': 'Phase 1 Part 1: Antitumor activity of BA3182'}, {'measure': 'Confirmed best overall response best overall response (BOR)', 'timeFrame': 'Up to 24 months', 'description': 'Phase 1: Antitumor activity of BA3182'}, {'measure': 'Confirmed duration of response (DOR)', 'timeFrame': 'Up to 24 months', 'description': 'Phase 1: Antitumor activity of BA3182'}, {'measure': 'Confirmed progression-free survival (PFS)', 'timeFrame': 'Up to 24 months', 'description': 'Phase 1: Antitumor activity of BA3182'}, {'measure': 'Confirmed disease control rate (DCR)', 'timeFrame': 'Up to 24 months', 'description': 'Phase 1: Antitumor activity of BA3182'}, {'measure': 'Confirmed time to response (TTR)', 'timeFrame': 'Up to 24 months', 'description': 'Phase 1: Antitumor activity of BA3182'}, {'measure': 'Confirmed overall survival (OS)', 'timeFrame': 'Up to 24 months', 'description': 'Phase 1: Antitumor activity of BA3182'}, {'measure': 'Confirmed percent change from baseline in target lesion sum of diameters.', 'timeFrame': 'Up to 24 months', 'description': 'Phase 1: Antitumor activity of BA3182'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': 'Up to 24 months', 'description': 'Phase 1: Pharmacokinetics of BA3182'}, {'measure': 'Peak Plasma Concentration (Cmax) Phase 1: Pharmacokinetics', 'timeFrame': 'Up to 24 months', 'description': 'Phase 1: Pharmacokinetics of BA3182'}, {'measure': 'Incidence of anti-drug antibody (ADAs) to BA3182 Phase 1: Pharmacokinetics Phase 1: Immunogenicity', 'timeFrame': 'Up to 24 months', 'description': 'Phase 1: Immunogenicity of BA3182'}, {'measure': 'Incidence of neutralizing antibodies (nAbs) to BA3182.', 'timeFrame': 'Up to 24 months', 'description': 'Phase 1: Immunogenicity of BA3182'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced', 'Metastatic', 'Cancer'], 'conditions': ['Advanced Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess safety and efficacy of BA3182 in Advanced Adenocarcinoma', 'detailedDescription': 'This is a multi-center, open-label, Phase 1 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3182 in patients with advanced adenocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma\n* Age ≥ 18 years\n* Adequate renal function\n* Adequate liver function\n* Adequate hematological function\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Patients must not have clinically significant cardiac disease.\n* Patients must not have known non-controlled CNS metastasis.\n* Patients must not have active autoimmune disease or a documented history of autoimmune disease.\n* Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as wellas known or suspected allergy or intolerance to any agent given during this study.\n* Patients must not incomplete recovery from the effects of major surgery or significant traumatic injury before the first dose of study treatment.\n* Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.\n* Patients must not be women who are pregnant or breast feeding.'}, 'identificationModule': {'nctId': 'NCT05808634', 'briefTitle': 'Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioAtla, Inc.'}, 'officialTitle': 'An Open-label, Multicenter, Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Efficacy of BA3182, a Bispecific Epithelial Cell Adhesion Molecule (EpCAM)/CD3 Antibody, in Patients With Advanced Adenocarcinoma', 'orgStudyIdInfo': {'id': 'BA3182-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BA3182', 'description': 'All Patients will receive BA3182', 'interventionNames': ['Drug: BA3182']}], 'interventions': [{'name': 'BA3182', 'type': 'DRUG', 'description': 'Conditionally active biologic (CAB)-bispecific T-cell engager antibody construct targeting EpCAM', 'armGroupLabels': ['BA3182']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92697', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chao Family Comprehensive Cancer Center', 'role': 'CONTACT', 'email': 'ucstudy@hs.uci.edu', 'phone': '877-827-8839'}], 'facility': 'UC Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lorraine Martinez Seng', 'role': 'CONTACT', 'email': 'Lorraine.Martinez@med.usc.edu', 'phone': '323-865-3000'}], 'facility': 'USC Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ingrid Palma', 'role': 'CONTACT', 'email': 'ingrid.palma@yale.edu', 'phone': '203-833-1034'}], 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Office', 'role': 'CONTACT', 'email': 'cancer@northwestern.edu', 'phone': '312-695-1301'}], 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Omer Qazi', 'role': 'CONTACT', 'email': 'omerqazi@uic.edu', 'phone': '312-413-1069'}], 'facility': 'University of Illinois', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clarice Zuccaro', 'role': 'CONTACT', 'email': 'zuccaroc@karmanos.org', 'phone': '313-576-9375'}], 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Abby Reed', 'role': 'CONTACT', 'email': 'abby.reed@thechristhospital.com', 'phone': '513-585-0844'}], 'facility': 'The Christ Hospital Cancer Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Principal Investigator', 'role': 'CONTACT', 'email': 'Madison.Conces@UHHospitals.org', 'phone': '216-844-3951'}], 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Phase 1 Clinical Trials', 'role': 'CONTACT', 'email': 'phase1clinicaltrial@fredhutch.org', 'phone': '206-606-7551'}], 'facility': 'Fred Hutch Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'BioAtla Medical Affairs', 'role': 'CONTACT', 'email': 'medicalaffairs@bioatla.com', 'phone': '858-558-0708', 'phoneExt': '3333'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioAtla, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}