Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-27 @ 12:25 AM
Study NCT ID:
NCT05115292
Status:
UNKNOWN
Last Update Posted:
2023-11-09
First Post:
2021-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First-in-Human, Phase 1 Dose-Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BJ-005 in Patients With Advanced Solid Tumor or Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-07', 'studyFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2021-10-29', 'lastUpdatePostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the incidence and frequency of adverse events following intravenous (IV) infusion of BJ-005 in patients with advanced solid tumor or lymphoma. The assessment will be conducted per CTCAE 5.0 throughout the conduct of the study.', 'timeFrame': '60 days after the last dose'}, {'measure': 'To determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of BJ-005 following IV infusion in patients with advanced solid tumor or lymphoma.', 'timeFrame': '60 days after the last dose'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumor or Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is a first-in-human, Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of BJ-005 in patients with advanced solid tumor or lymphoma. BJ-005 is a recombinant bifunctional molecule, composed of a humanized anti-PD-L1 IgG1 monoclonal antibody (mAb) fused with a portion of the extracellular domain of human TGF-β receptor II (TGF-βRII).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female ≥ 18 years.\n2. Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.\n3. Histologically or cytologically confirmed advanced solid tumors or lymphoma\n4. Measurable or evaluable disease per RECIST v1.1\n5. ECOG performance status 0 or 1\n6. Life expectancy ≥3 months\n7. Adequate hepatic function\n8. Calculated creatinine clearance (CrCL) \\> 50 mL/min (Cockroft-Gault Equation)\n9. Adequate Hematological function\n10. Prothrombin time, international normalized ratio or activated partial thromboplastin time \\< 1.5 × ULN\n11. Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy\n\nExclusion Criteria:\n\n1. Prior therapy with anti PD-L1/TGFβRⅡ targeting treatment.\n2. Symptomatic primary central nervous system (CNS) tumor of CNS metastases.\n3. Uncontrolled hypertension.\n4. Significant thrombotic or hemorrhagic events.\n5. Prior CAR-T therapy\n6. Severe cardiovascular disease.\n7. Active infection requiring therapy\n8. Active HIV, hepatitis B or hepatitis C virus\n9. Active tuberculosis\n10. Anticancer therapy or radiation therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to study entry\n11. Pregnant or breast-feeding females\n12. Active or history of autoimmune disease or inflammatory disorders'}, 'identificationModule': {'nctId': 'NCT05115292', 'briefTitle': 'A First-in-Human, Phase 1 Dose-Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BJ-005 in Patients With Advanced Solid Tumor or Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'BJ Bioscience, Inc.'}, 'officialTitle': 'A First-in-Human, Multicenter, Open-label, Phase 1 Dose-Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BJ-005 in Patients With Advanced Solid Tumor or Lymphoma', 'orgStudyIdInfo': {'id': 'BJ-005-01-001US'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm1', 'description': 'BJ-005 dose escalation', 'interventionNames': ['Biological: BJ-005']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'BJ-005 cohort expansion', 'interventionNames': ['Biological: BJ-005']}], 'interventions': [{'name': 'BJ-005', 'type': 'BIOLOGICAL', 'description': 'dosed with intravenous infusion', 'armGroupLabels': ['Arm 2', 'Arm1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic - Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic - Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34952', 'city': 'Port Saint Lucie', 'state': 'Florida', 'country': 'United States', 'facility': 'Hematology/Oncology Assoc. of the Treasure Coast', 'geoPoint': {'lat': 27.29393, 'lon': -80.35033}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic - Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina BioOncology', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '78758', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Next Oncology', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Vicky Gao, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BJ Bioscience, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BJ Bioscience, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}