Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-31 @ 10:49 PM
Study NCT ID:
NCT03715933
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2018-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012512', 'term': 'Sarcoma, Ewing'}, {'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D012516', 'term': 'Osteosarcoma'}, {'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D000077204', 'term': 'Temozolomide'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 321}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2018-10-11', 'studyFirstSubmitQcDate': '2018-10-19', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Anti-tumor activity of INBRX-109', 'timeFrame': 'Up to 8 years', 'description': 'Tumor response will be determined by RECISTv1.1.'}, {'measure': 'Potential predictive response biomarkers', 'timeFrame': 'Up to 8 years', 'description': 'Evaluate the relationship between potential predictive response biomarkers and efficacy of INBRX-109'}], 'primaryOutcomes': [{'measure': 'Frequency and severity of adverse events of INBRX-109', 'timeFrame': 'Up to 8 years', 'description': 'Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.'}, {'measure': 'Evaluating Tumor Response for colorectal cancers and Ewing sarcoma', 'timeFrame': 'Up to 8 years', 'description': 'Evaluating how the tumor responds to treatment by measuring the number of patients with colorectal cancer and Ewing sarcoma that experience tumor shrinkage and for how long.'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity of INBRX-109', 'timeFrame': 'Up to 8 years', 'description': 'Frequency of ant-drug antibodies (ADA) against INBRX-109 will be determined.'}, {'measure': 'Characterize the pharmacokinetics of INBRX-109 as a single agent, and of INBRX-109 in combination with distinct chemotherapies.', 'timeFrame': 'Up to 8 years', 'description': 'A measurement which indicates how the body processes INBRX-109 and how long it stays in the system.'}, {'measure': 'Median progression-free survival for colorectal adenocarcinoma and Ewing sarcoma.', 'timeFrame': 'Up to 8 years', 'description': 'Progression-free survival is defined as the time from start of study treatment until documented disease progression or death.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phase 1', 'Phase 1 Clinical Trial', 'Solid Tumors', 'Sarcoma', 'DR5', 'Ewing Sarcoma'], 'conditions': ['Ewing Sarcoma']}, 'referencesModule': {'references': [{'pmid': '37265425', 'type': 'DERIVED', 'citation': "Subbiah V, Chawla SP, Conley AP, Wilky BA, Tolcher A, Lakhani NJ, Berz D, Andrianov V, Crago W, Holcomb M, Hussain A, Veldstra C, Kalabus J, O'Neill B, Senne L, Rowell E, Heidt AB, Willis KM, Eckelman BP. Preclinical Characterization and Phase I Trial Results of INBRX-109, A Third-Generation, Recombinant, Humanized, Death Receptor 5 Agonist Antibody, in Chondrosarcoma. Clin Cancer Res. 2023 Aug 15;29(16):2988-3003. doi: 10.1158/1078-0432.CCR-23-0974."}]}, 'descriptionModule': {'briefSummary': 'This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or females aged ≥12 to less than 85 years for Ewing sarcoma and 18 to less than 85 years of age for other tumors.\n2. Part 3 combination therapy expansion tumor types:\n\n * Histologically confirmed Ewing sarcoma with a classical fusion: Patients with locally advanced or metastatic, unresectable, relapsed, or refractory disease who have received at least 1 but no more than 2 prior lines of systemic treatment with a preferred first line chemotherapy regimens.\n * Colorectal adenocarcinoma: Patients with locally advanced or metastatic, unresectable disease, who have received at least 2 but no more than 3 prior lines of systemic therapy.\n3. Measurable disease as defined by RECISTv1.1 (or modified RECIST for mesothelioma) criteria.\n4. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.\n5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1, or Karnofsky Performance Status score of ≥60, or Lansky Play-Performance Scale for Children score ≥60 (for patients less than 16 years).\n6. Estimated life expectancy of at least 12 weeks.\n7. Availability of archival tissue or fresh cancer biopsy are mandatory.\n\nExclusion Criteria:\n\n1. Prior treatment with or exposure to DR5 agonists.\n2. Receipt of any anticancer therapy (including investigational agents) within 4 weeks or within 5 half-lives prior to the first dose of study treatment. Exceptions per protocol.\n3. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.\n4. Receipt of radiotherapy within 4 weeks prior to the first dose of study treatment, and liver-directed within 12 months prior to the first dose of study drug.\n5. Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exceptions per protocol.\n6. Prior or concurrent malignancies. Exceptions per protocol.\n7. Hematologic malignancies.\n8. Symptomatic active primary CNS tumors, leptomeningeal disease, and CNS metastases. Exceptions per protocol. Patients with any evidence or history of multiple sclerosis (MS) or other demyelinating disorders are excluded.\n9. Chronic liver diseases including fatty liver. Exception: Patients \\< 45 years old with fatty liver disease may be accepted as long as adequate hepatic function as defined in the inclusion/exclusion criteria is confirmed.\n10. Acute viral or toxic liver disease within 12 months prior to the first dose of study drug.\n11. Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.\n12. Known sensitivity or contraindications to the following drugs:\n\n * Ewing sarcoma: irinotecan or TMZ\n * colorectal adenocarcinoma: FU, leucovorin, or irinotecan\n13. Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease less than 3 months prior to enrollment.\n14. Acute, hemodynamically significant deep vein thrombosis or clinically significant pulmonary embolism not resolved or stable for at least 3 months prior to the start of study treatment.\n15. Major surgery within 4 weeks prior to enrollment on this trial.\n16. Systemic infection requiring antibiotics within 2 weeks prior to the first dose of study drug.\n17. Other exclusion criteria per protocol.'}, 'identificationModule': {'nctId': 'NCT03715933', 'briefTitle': 'Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Inhibrx Biosciences, Inc'}, 'officialTitle': 'An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas', 'orgStudyIdInfo': {'id': 'Ph1 INBRX-109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation (Complete)', 'description': 'INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas.', 'interventionNames': ['Drug: INBRX-109']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Malignant Pleural Mesothelioma (Complete)', 'description': 'Subjects with malignant pleural mesothelioma will be treated with single-agent INBRX-109 at either the MTD or RP2D.', 'interventionNames': ['Drug: INBRX-109']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Gastric Adenocarcinoma (Complete)', 'description': 'Subjects with gastric adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.', 'interventionNames': ['Drug: INBRX-109']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Colorectal Adenocarcinoma (Complete)', 'description': 'Subjects with colorectal (CRC) adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.', 'interventionNames': ['Drug: INBRX-109']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Sarcomas (Complete)', 'description': 'Subjects with certain sarcoma subtypes will be treated with single-agent INBRX-109 at either the MTD or RP2D.', 'interventionNames': ['Drug: INBRX-109']}, {'type': 'EXPERIMENTAL', 'label': 'Combination Expansion Malignant Pleural Mesothelioma (Complete)', 'description': 'Subjects with malignant pleural mesothelioma will be treated with INBRX-109 in combination with chemotherapies (carboplatin, cisplatin, carboplatin and pemetrexed, or cisplatin and pemetrexed)', 'interventionNames': ['Drug: INBRX-109', 'Drug: carboplatin', 'Drug: pemetrexed']}, {'type': 'EXPERIMENTAL', 'label': 'Combination Expansion Pancreatic Adenocarcinoma (Complete)', 'description': 'Subjects with pancreatic adenocarcinoma will be treated with INBRX-109 in combination with 5FU/irinotecan based chemotherapy', 'interventionNames': ['Drug: INBRX-109', 'Drug: Irinotecan', 'Drug: Leucovorin', 'Drug: Fluorouracil']}, {'type': 'EXPERIMENTAL', 'label': 'Combination Expansion Ewing Sarcoma', 'description': 'Subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide', 'interventionNames': ['Drug: INBRX-109', 'Drug: Irinotecan', 'Drug: Temozolomide']}, {'type': 'EXPERIMENTAL', 'label': 'Combination Expansion Colorectal Adenocarcinoma (Complete)', 'description': 'Subjects with colorectal adenocarcinoma will be treated with INBRX-109 in combination with FOLFIRI based chemotherapy', 'interventionNames': ['Drug: INBRX-109', 'Drug: Irinotecan', 'Drug: Leucovorin', 'Drug: Fluorouracil']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Solid Tumors (Complete)', 'description': 'Subjects with Solid tumors and high BMI will be treated with single-agent INBRX-109 at either the MTD or RP2D.', 'interventionNames': ['Drug: INBRX-109']}, {'type': 'EXPERIMENTAL', 'label': 'Combination Expansion SDH-deficient solid tumors or GIST (Complete)', 'description': 'Subjects with SDH-deficient solid tumors or GIST will be treated with INBRX-109 in combination with temozolomide', 'interventionNames': ['Drug: INBRX-109', 'Drug: Temozolomide']}], 'interventions': [{'name': 'INBRX-109', 'type': 'DRUG', 'description': 'Tetravalent DR5 Agonist Antibody', 'armGroupLabels': ['Combination Expansion Colorectal Adenocarcinoma (Complete)', 'Combination Expansion Ewing Sarcoma', 'Combination Expansion Malignant Pleural Mesothelioma (Complete)', 'Combination Expansion Pancreatic Adenocarcinoma (Complete)', 'Combination Expansion SDH-deficient solid tumors or GIST (Complete)', 'Dose Escalation (Complete)', 'Expansion Colorectal Adenocarcinoma (Complete)', 'Expansion Gastric Adenocarcinoma (Complete)', 'Expansion Malignant Pleural Mesothelioma (Complete)', 'Expansion Sarcomas (Complete)', 'Expansion Solid Tumors (Complete)']}, {'name': 'Irinotecan', 'type': 'DRUG', 'description': 'Chemotherapy', 'armGroupLabels': ['Combination Expansion Colorectal Adenocarcinoma (Complete)', 'Combination Expansion Ewing Sarcoma', 'Combination Expansion Pancreatic Adenocarcinoma (Complete)']}, {'name': 'Temozolomide', 'type': 'DRUG', 'description': 'Chemotherapy', 'armGroupLabels': ['Combination Expansion Ewing Sarcoma', 'Combination Expansion SDH-deficient solid tumors or GIST (Complete)']}, {'name': 'carboplatin', 'type': 'DRUG', 'description': 'chemotherapy', 'armGroupLabels': ['Combination Expansion Malignant Pleural Mesothelioma (Complete)']}, {'name': 'pemetrexed', 'type': 'DRUG', 'description': 'chemotherapy', 'armGroupLabels': ['Combination Expansion Malignant Pleural Mesothelioma (Complete)']}, {'name': 'Leucovorin', 'type': 'DRUG', 'description': 'chemotherapy', 'armGroupLabels': ['Combination Expansion Colorectal Adenocarcinoma (Complete)', 'Combination Expansion Pancreatic Adenocarcinoma (Complete)']}, {'name': 'Fluorouracil', 'type': 'DRUG', 'description': 'chemotherapy', 'armGroupLabels': ['Combination Expansion Colorectal Adenocarcinoma (Complete)', 'Combination Expansion Pancreatic Adenocarcinoma (Complete)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'HonorHealth Research Institute', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90212', 'city': 'Beverly Hills', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Francisco Capilla', 'role': 'CONTACT', 'email': 'Franciscoc@nextgenonc.com', 'phone': '424-777-0708'}, {'name': 'Kamalesh Sankhala, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Precision NextGen Oncology and Research', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heather Lewis', 'role': 'CONTACT', 'email': 'healewis@coh.org', 'phone': '626-256-4673'}, {'name': 'New Patient Services Coordinator', 'role': 'CONTACT', 'email': 'newpatientref@coh.org', 'phone': '1-800-826-4673'}, {'name': 'Marwan Fakih, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90067', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carla Collier', 'role': 'CONTACT', 'email': 'carla.collier@valkyrieclinicaltrials.com'}, {'name': 'David Berz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Valkyrie Clinical Trials', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92093', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Bienvenida', 'role': 'CONTACT', 'email': 'jbienvenida@health.ucsd.edu', 'phone': '858-822-4907'}, {'name': 'Shakeela Dad', 'role': 'CONTACT', 'email': 'sdad@health.ucsd.edu'}, {'name': 'Adam Burgoyne, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Diego (UCSD) - Moores Cancer Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'June Dy', 'role': 'CONTACT', 'email': 'June.Dy@ucsf.edu', 'phone': '415-866-7674'}, {'name': 'Varun Monga, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Francisco (UCSF)', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Victoria Chua-Alcala', 'role': 'CONTACT', 'email': 'vchua@sarcomaoncology.com', 'phone': '310-552-9999'}, {'name': 'Sant P Chawla, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sarcoma Oncology Center', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michaela Riley', 'role': 'CONTACT', 'email': 'michaela.riley@cuanschutz.edu'}, {'name': 'Christopher Lieu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kimberly Homere', 'role': 'CONTACT', 'email': 'kimberly.homere@emory.edu', 'phone': '404-778-6583'}, {'name': 'Olatunji Alese, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University - Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Myron Hepner', 'role': 'CONTACT', 'email': 'mhepner@med.umich.edu'}, {'name': 'Rashmi Chugh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 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