Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-04-07 @ 10:55 AM
Study NCT ID:
NCT05271604
Status:
COMPLETED
Last Update Posted:
2025-09-26
First Post:
2022-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D000068818', 'term': 'Cetuximab'}], '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2022-02-28', 'studyFirstSubmitQcDate': '2022-02-28', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirmed Objective Response Rate (ORR) per RECIST v1.1', 'timeFrame': 'Up to 24 months', 'description': 'Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1'}, {'measure': 'Incidence of Adverse Events or Serious Adverse Events as assessed by CTCAE v5', 'timeFrame': 'Up to 24 months', 'description': 'Measured by frequency and severity of adverse events as assessed by CTCAE v5'}], 'secondaryOutcomes': [{'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to 24 months', 'description': 'Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to 24 months', 'description': 'Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first.'}, {'measure': 'Best overall response (BOR)', 'timeFrame': 'Up to 24 months', 'description': 'All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Up to 24 months', 'description': 'Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks.'}, {'measure': 'Time to response (TTR)', 'timeFrame': 'Up to 24 months', 'description': 'Time from the first dose of investigational product until the first documentation of OR.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 24 months', 'description': 'Time from the first dose of BA3021 treatment until death due to any cause.'}, {'measure': 'Complete response (CR)', 'timeFrame': 'Up to 24 months', 'description': 'Proportion of patients with a best overall response of confirmed CR'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer'], 'conditions': ['Head and Neck Cancer', 'Squamous Cell Carcinoma of Head and Neck', 'Recurrent Squamous Cell Carcinoma of the Head and Neck', 'Metastatic Cancer', 'Metastatic Squamous Cell Carcinoma of the Head and Neck']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, open-label Phase 2 study designed to evaluate the efficacy and safety of BA3021 as monotherapy and combination therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Patients may not have a primary tumor site of nasopharynx (any histology).\n* Neoadjuvant/induction setting (Cohort N1): Patient with newly diagnosed Stage III SCCHN who are eligible for induction therapy with resectable tumors. No prior treatments, including surgery, radiation, or systemic treatment, for SCCHN are allowed.\n* Recurrent or metastatic setting: Histologically or cytologically confirmed recurrent or metastatic SCCHN Stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).\n* First-line - Combination Cohorts (C1 and C2): Patients must have NO prior systemic therapy administered in the locally recurrent or metastatic setting. Previous treatments with PD-1/L1 inhibitor or anti-CTLA-4 treatment are not allowed.\n* Second-line (Combination Cohort C3) and Second-line+ (Monotherapy Cohorts M1 and M2): Patients must have documented treatment failure of no more than one approved PD-1/L1 inhibitor either administered alone or in combination.\n\nPatients must have measurable disease.\n\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 a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.\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 are breast feeding.'}, 'identificationModule': {'nctId': 'NCT05271604', 'briefTitle': 'A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioAtla, Inc.'}, 'officialTitle': 'A Phase 2 Open-Label Study of Ozuriftamab Vedotin (BA3021) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck', 'orgStudyIdInfo': {'id': 'BA3021-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort M1', 'description': 'Monotherapy BA3021 Q2W dosing regimen', 'interventionNames': ['Biological: Ozuriftamab Vedotin']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort M2', 'description': 'Monotherapy BA3021 2Q3W dosing regimen', 'interventionNames': ['Biological: Ozuriftamab Vedotin']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort N1', 'description': 'Neoadjuvant/induction setting combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen prior to surgery.', 'interventionNames': ['Biological: Ozuriftamab Vedotin', 'Biological: Pembrolizumab', 'Biological: Evalstotug (BA3071)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C1', 'description': 'Combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen', 'interventionNames': ['Biological: Ozuriftamab Vedotin', 'Biological: Pembrolizumab', 'Biological: Evalstotug (BA3071)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C2', 'description': 'Combination therapy of BA3021 2Q3W dosing regimen, and pembrolizumab Q3W dosing regimen', 'interventionNames': ['Biological: Ozuriftamab Vedotin', 'Biological: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C3', 'description': 'Combination therapy of BA3021 2Q3W dosing regimen and cetuximab QW dosing regimen', 'interventionNames': ['Biological: Ozuriftamab Vedotin', 'Biological: Cetuximab']}], 'interventions': [{'name': 'Ozuriftamab Vedotin', 'type': 'BIOLOGICAL', 'description': 'Conditionally active biologic anti-ROR2 antibody drug conjugate', 'armGroupLabels': ['Cohort C1', 'Cohort C2', 'Cohort C3', 'Cohort M1', 'Cohort M2', 'Cohort N1']}, {'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'description': 'PD-1 inhibitor', 'armGroupLabels': ['Cohort C1', 'Cohort C2', 'Cohort N1']}, {'name': 'Evalstotug (BA3071)', 'type': 'BIOLOGICAL', 'description': 'Conditionally active biologic anti-CTLA-4 checkpoint blockade antibody', 'armGroupLabels': ['Cohort C1', 'Cohort N1']}, {'name': 'Cetuximab', 'type': 'BIOLOGICAL', 'otherNames': ['Erbitux'], 'description': 'Epidermal growth factor receptor (EGFR) antagonist', 'armGroupLabels': ['Cohort C3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Helen Graham Cancer Center', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Cancer Institute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University Medical Siteman Cancer Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioAtla, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}