Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT01279603
Status:
COMPLETED
Last Update Posted:
2014-09-19
First Post:
2011-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of GO-203-2C Given Intravenously in Patients With Advanced Solid Tumors Including Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-18', 'studyFirstSubmitDate': '2011-01-11', 'studyFirstSubmitQcDate': '2011-01-18', 'lastUpdatePostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '24 months', 'description': 'To determine the maximum tolerated dose (MTD) and identify the dose limiting toxicities (DLT) of GO-203-2c - To establish the dose of GO-203-2c recommended for future phase II protocols'}]}, 'conditionsModule': {'keywords': ['Cancer'], 'conditions': ['Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '40443562', 'type': 'DERIVED', 'citation': 'Gorodetska I, Samusieva A, Lahuta T, Ponomarova O, Socha O, Kozeretska I. Exploring New Frontiers: Alternative Breast Cancer Treatments Through Glycocalyx Research. Breast J. 2025 May 22;2025:9952727. doi: 10.1155/tbj/9952727. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial is about testing GO-203-2c, which is a newly discovered compound that binds to an oncoprotein (a cancer causing protein) called MUC1 (which is over-expressed in many cancers). By binding to MUC1, GO-203-2c eventually causes tumor cell death in laboratory studies.\n\nThis study is being done to:\n\n* Test the safety of GO-203-2c and see what effects (good and bad) it has on you and your cancer\n* Find the highest dose of GO-203-2c that can be given without causing bad side effects\n* Examine how much GO-203-2c is in the blood at certain times after it is given and how quickly the body gets rid of it\n* Observe whether there is any effect of GO-203-2c on the size and activity of cancer in your body'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed solid tumors or lymphomas\n* Tumor progression observed after receiving standard/approved systemic chemotherapy and/or immunotherapy including monoclonal antibodies, or when there is no approved or effective therapy\n* One or more measureable tumors by radiological evaluation\n* Karnofsky performance ≥ 70%\n* Life expectancy of ≥ 3 months\n* Age ≥ 18 years\n* Signed, written IRB-approved informed consent\n* Negative pregnancy test (if female)\n* Adequate liver function:\n* Bilirubin less than or equal to 1.5 x upper limit of normal (ULN)\n* AST (SGOT), ALT (SGPT) and Alkaline phosphatase less than or equal to 2.5 x ULN (if liver metastases are present, then less than or equal to 5 x ULN is allowed)\n* Adequate renal function:\n* Serum creatinine within normal limits, OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with serum creatinine above institutional ULN.\n* Corrected serum calcium ≥ lower limit of the institutional normal range (LLN)\n* Serum phosphorus level ≥ LLN\n* Adequate hematologic function:\n* Absolute Neutrophil Count ≥ 1500 cells/mm3\n* Platelet count ≥ 100,000 (cells/mm3)\n* Hemoglobin ≥ 9 g/dL\n* Urinalysis:\n* No clinically significant abnormalities\n* Adequate coagulation function:\n* PT ≤ 1.25 x ULN\n* PTT ≤ 1.25 x ULN\n* For men and women of child-producing potential, agreement to use effective contraceptive methods during the study\n\nExclusion Criteria:\n\n* New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG\n* Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy\n* Pregnant or nursing women. NOTE: Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Major surgery within 4 weeks prior to Day 1, or not fully recovered by Day 1\n* Minor surgery within 2 weeks prior to Day 1, or not fully recovered by Day 1\n* Treatment with radiation therapy within 4 weeks prior to Day 1.\n* Received systemic chemotherapy or monoclonal antibody or other immunotherapy within 4 weeks prior to Day 1 (exceptions: 6 weeks for nitrosourea, mitomycin C, or any agent with a known treatment effect \\> 4 weeks' duration), or not fully recovered from any side effects from previous therapy by Day 1\n* History of allergic reactions attributed to excipients or chemical products used in the final GO-203-2c drug formulation\n* Known infection with HIV, hepatitis B, or hepatitis C.\n* Subjects with risk factors for gastrointestinal perforation or pulmonary hemorrhage (e.g. unresected luminal intestinal cancers; abdominal carcinomatosis within 3 months before the first dose of study drug, abdominal fistula, acute diverticulitis, peptic ulcer disease, irritable bowel syndrome, Crohn's disease, pulmonary hemorrhage, hemoptysis, or tuberculosis)\n* Currently receiving or having received treatment with any other investigational agent within 4 weeks prior to Day 1, or not fully recovered from toxicities of prior treatment by Day 1\n* Serious and/or poorly controlled non-malignant disease (including but not limited to, ongoing or active infection, hydronephrosis, hypertension, diabetes, or other conditions) that could compromise protocol objectives in the opinion of the Investigator and/or the sponsor. Patients with such conditions should be discussed with the Medical Monitor prior to enrollment. All medical conditions must be NCI CTCAE Grade 1 or lower at baseline.\n* Unwillingness or inability to comply with requirements of this protocol"}, 'identificationModule': {'nctId': 'NCT01279603', 'briefTitle': 'Study of GO-203-2C Given Intravenously in Patients With Advanced Solid Tumors Including Lymphomas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genus Oncology, LLC'}, 'officialTitle': 'A Phase 1, Multi-center, Open-label, Dose-escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GO-203-2c Given Intravenously Daily X21 Repeated Every 28 Days in Patients With Advanced Solid Tumors Including Lymphomas', 'orgStudyIdInfo': {'id': 'GO-2C-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GO-203-2c', 'interventionNames': ['Drug: GO-203-2c']}], 'interventions': [{'name': 'GO-203-2c', 'type': 'DRUG', 'description': 'GO-203-2c Injection is a non-preserved, sterile, ready-to-use liquid dosage form provided in a glass vial with rubber closure and crimp seal. Injection will be added to the contents of an intravenous bag (of 0.9% NS, D5W or sterile water) to a final concentration of between 0.03 - 0.3 mg/ml (preferable in 100 mls or greater) and administered as a single agent intravenously over 60 minutes. A treatment cycle will consist of a daily IV dose administered for 21 consecutive days followed by a 7 day rest.', 'armGroupLabels': ['GO-203-2c']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'TGen Clinical Research Service', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genus Oncology, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}