Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT04900818
Status:
RECRUITING
Last Update Posted:
2025-01-03
First Post:
2021-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of TJ033721 (givastomig) in Subjects with Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D004358', 'term': 'Drug Therapy'}], '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'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 168}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-02', 'studyFirstSubmitDate': '2021-05-20', 'studyFirstSubmitQcDate': '2021-05-20', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicities (DLTs)', 'timeFrame': '28 days'}, {'measure': 'Incidence and severity of AEs', 'timeFrame': 'Up to 100 days post last dose', 'description': 'The CTCAE criteria will be used to assess adverse events on this trial.'}, {'measure': 'Maximum tolerated or administered dose (MTD, MAD)', 'timeFrame': '28 Days', 'description': 'Based on DLT definitions'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic (PK) Parameters: AUC∞', 'timeFrame': 'Up to 100 days post last dose', 'description': 'Area under the curve from time zero extrapolated to infinity (AUC∞)'}, {'measure': 'Pharmacokinetic (PK) Parameters: AUCt', 'timeFrame': 'up to 100 days post last dose', 'description': 'AUC from time zero to the time of the last quantifiable concentration (AUC0-t)'}, {'measure': 'Pharmacokinetic (PK) Parameters: Cmax', 'timeFrame': 'up to 100 days post last dose', 'description': 'Maximum observed concentration'}, {'measure': 'Pharmacokinetic Parameters: Tmax', 'timeFrame': 'up to 100 days post last dose', 'description': 'Time of peak concentration (Tmax)'}, {'measure': 'Pharmacokinetic Parameters: T1/2', 'timeFrame': 'up to 100 days post last dose', 'description': 'Investigational Product (IP) half-life (T1/2)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor', 'Advanced Cancer', 'Metastatic Cancer', 'Gastric Cancer', 'Gastroesophageal Junction Carcinoma', 'Esophageal Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPart 1 - Monotherapy\n\n• Subjects with advanced or metastatic solid tumor in subjects whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard treatment options.\n\nPart 2 - Combination Therapy Subjects with treatment naïve locally advanced, unresectable or metastatic gastric, GEJ, esophageal adenocarcinoma;\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with adequate organ function\n* Have known PD-L1 status with prior testing by immunohistochemistry and a corresponding combined positive score (CPS)\n\nFor dose expansion and Part 2 Combination subjects:\n\n• Must have CLDN18.2-positive tumor expression\n\nExclusion Criteria\n\n* Prior exposure to CLDN18.2 -targeted therapy\n* Prior exposure to 4-1BB agonists\n* Second malignancy within the last 3 years with the exception of cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma or cervical carcinoma in situ\n* Known active or chronic Hepatitis B or Hepatitis C, other hepatitides\n* Unstable/active ulcer or digestive tract bleeding within 6 weeks\n* Active autoimmune disease requiring systemic treatment within the past 2 years\n* Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment\n* Known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment;\n* New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, severe/unstable angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack (TIA), arterial embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) in the previous 6 months\n* Diagnosis of immunodeficiency such as known active HIV\n* Any active infection requiring parenteral treatment\n\nFor Part 2 Combination subjects:\n\n• Prior treatment with anti-PD-1 or PD-L1'}, 'identificationModule': {'nctId': 'NCT04900818', 'briefTitle': 'Study of TJ033721 (givastomig) in Subjects with Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'I-Mab Biopharma US Limited'}, 'officialTitle': 'A Phase 1 Study of TJ033721 in Subjects with Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'TJ033721STM101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TJ033721 (givastomig)', 'description': 'Dose Escalation: TJ033721 will be administered at up to 8 dose levels (0.1, 0.3, 1, 3, 5, 8, 12 and 15 mg/kg) bi weekly (Q2W) and 1 dose level (18 mg/kg) every 3 weeks (Q3W)\n\nDuring dose expansion, TJ033721 will be administered Q2W, starting at the RP2D or MTD in dose escalation.', 'interventionNames': ['Drug: TJ033721 (givastomig)']}, {'type': 'EXPERIMENTAL', 'label': 'TJ033721 (givastomig) in combination with nivolumab and chemotherapy', 'description': 'TJ033721 will be administered in combination with nivolumab and chemotherapy', 'interventionNames': ['Drug: TJ033721 (givastomig) , nivolumab, chemotherapy']}], 'interventions': [{'name': 'TJ033721 (givastomig)', 'type': 'DRUG', 'description': 'Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)', 'armGroupLabels': ['TJ033721 (givastomig)']}, {'name': 'TJ033721 (givastomig) , nivolumab, chemotherapy', 'type': 'DRUG', 'description': 'Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb), nivolumab, chemotherapy', 'armGroupLabels': ['TJ033721 (givastomig) in combination with nivolumab and chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Stern Center for Cancer Clinical Trials and Research', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UCHealth Cancer Care - Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '47905', 'city': 'Layfayette', 'state': 'Indiana', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Horizon Oncology Research, LLC.'}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mass General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NYU Langone', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Carolina BioOncology Institute', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Mary Crowley Cancer Research', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UW Carbone Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '230601', 'city': 'Hefei', 'state': 'Anhui', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'The Second Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510655', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '150086', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'HARBIN Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '45003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430079', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Hubei Cancer Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '110499', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Tianjin Medical University Cancer Institute and Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '3110020', 'city': 'Hongzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital, Zhejiang University School of Medicine'}], 'centralContacts': [{'name': 'US Site Head', 'role': 'CONTACT', 'email': 'us.info@i-mabbiopharma.com', 'phone': '301-294-4408'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'I-Mab Biopharma US Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}