Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-01-06 @ 6:55 PM
Study NCT ID:
NCT02482168
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2015-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the CD40 Agonistic Monoclonal Antibody APX005M
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723517', 'term': 'sotigalimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-19', 'studyFirstSubmitDate': '2015-06-11', 'studyFirstSubmitQcDate': '2015-06-23', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose limiting toxicities', 'timeFrame': 'Up to 28 days following first dose of APX005M', 'description': 'The rate of DLTs will be assessed in approximately 56 subjects. DLTs will include Grade 4 neutropenia, anemia, thrombocytopenia, Grade 3or 4 nausea, cytokine release syndrome and other Grade 3 non-hematological toxicity'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Through up to approximately 4 weeks following last dose of APX005M', 'description': 'Incidence and severity of AEs and specific laboratory abnormalities graded according to NCI-CTCAE, v4.03'}], 'secondaryOutcomes': [{'measure': 'Blood concentrations of APX005M', 'timeFrame': 'Predose, 0.5, 1, 2, 4, 24, 48 and 168 hours following first and third dose of APX005M', 'description': 'PK parameters of APX005M'}, {'measure': 'Presence and titer of anti-APX005M antibodies', 'timeFrame': 'Prior to first dose, approximately 3, 6 and 9 weeks following first dose and approximately 4 weeks following last dose of APX005M', 'description': 'Assess incidence of anti-drug antibodies (ADA)'}, {'measure': 'Objective response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)', 'timeFrame': 'Every 8 weeks up to approximately 1 year following first dose of APX005M', 'description': 'Efficacy assessments will follow RECIST 1.1.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['immunotherapy', 'CD40'], 'conditions': ['Cancer', 'NSCLC', 'Melanoma', 'Urothelial Carcinoma', 'MSI-H', 'Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a phase 1 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M in adults with solid tumors. Study is intended to establish the maximum tolerated dose and the overall safety and tolerability of APX005M in 3 different administration schedules.', 'detailedDescription': 'APX005M-001 is an open-label study and comprises a dose-escalation portion of approximately 8 dose level cohorts, plus an expansion cohort.\n\nEligible subjects with solid tumors will receive intravenous APX005M every 3 week, every 2 week or every 1 week until disease progression, unacceptable toxicity or death, whichever occurs first.\n\nStudy objectives include:\n\n* Evaluate safety of APX005M\n* Determine the maximum tolerated dose of APX005M\n* Determine the pharmacokinetic parameters of APX005M: the maximal drug concentration (Cmax), area under the curve of serum concentration over time (Area Under the Curve/ AUC), and half-life (t½).\n* Preliminary assessment of clinical response'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Histologically documented diagnosis of solid tumor\n* For subjects in the every 2 week and every 1 week dosing cohorts histologically or cytologically documented diagnosis of urothelial carcinoma, melanoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, or any solid tumor with high microsatellite instability status (MSI-high)\n* No known effective therapy options are available\n* Measurable disease by RECIST 1.1\n* ECOG performance status of 0 or 1\n* Adequate bone marrow, liver and kidney function\n* No toxicities related to prior treatment related toxicities with the exception of alopecia and neuropathy\n* Negative pregnancy test for women of child bearing potential\n\nKey Exclusion Criteria:\n\n* Any history of or current hematologic malignancy\n* Major surgery or treatment with any other investigational agent within 4 weeks\n* Uncontrolled diabetes or hypertension\n* History of arterial thromboembolic event\n* History of congestive heart failure, symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction\n* Active known clinically serious infections'}, 'identificationModule': {'nctId': 'NCT02482168', 'briefTitle': 'Study of the CD40 Agonistic Monoclonal Antibody APX005M', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apexigen America, Inc.'}, 'officialTitle': 'Phase 1 Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Subjects With Solid Tumors', 'orgStudyIdInfo': {'id': 'APX005M-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APX005M every 3 week', 'description': 'Subjects receive APX005M intravenously every 3 week until disease progression, unacceptable toxicity or death.', 'interventionNames': ['Drug: APX005M']}, {'type': 'EXPERIMENTAL', 'label': 'APX005M every 2 week', 'description': 'Subjects receive APX005M intravenously every 2 week until disease progression, unacceptable toxicity or death.', 'interventionNames': ['Drug: APX005M']}, {'type': 'EXPERIMENTAL', 'label': 'APX005M every 1 week', 'description': 'Subjects receive APX005M intravenously every 1 week until disease progression, unacceptable toxicity or death.', 'interventionNames': ['Drug: APX005M']}], 'interventions': [{'name': 'APX005M', 'type': 'DRUG', 'description': 'APX005M is a CD40 agonistic monoclonal antibody', 'armGroupLabels': ['APX005M every 1 week', 'APX005M every 2 week', 'APX005M every 3 week']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of The University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Apexigen America, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apexigen America, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}