Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT01337505
Status:
COMPLETED
Last Update Posted:
2022-02-10
First Post:
2011-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Maximum Tolerated Dose (MTD) Study of INNO-206 in Subjects With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C575867', 'term': 'DOXO-EMCH'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-27', 'studyFirstSubmitDate': '2011-04-14', 'studyFirstSubmitQcDate': '2011-04-18', 'lastUpdatePostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'Up to 6 cycles (every 21 days)', 'description': 'Safety will be based on adverse events, tolerability, physical examinations, vital signs, ECG results, laboratory test results. MTD: If 2 of 5 subjects an any dose level experiences a grade 3 or 4 non-hematologic toxicity, or a platelet count \\<25,000/uL or a neutrophil count \\<500/uL lasting \\>7 days and/or associated with fever \\>38.5C, 3 more subjects will be entered at that dose level. If 2 of 3 of the additional subjects experience any of the above adverse events, the dose level immediately below will be identified as the MTD.'}], 'secondaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': 'Up to 6 cycles (every 21 days)', 'description': 'To evaluate the objective response reate (OR; RECIST 1.1 criteria). Changes in tumor measurements from baseline values that are confirmed by repeat assessments will be assigned a status of CR or PR. OR=CR+PR.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['INNO-206', 'Phase 1', 'DOXO-EMCH', 'Advanced solid tumors'], 'conditions': ['Malignant Solid Tumour']}, 'descriptionModule': {'briefSummary': 'This is a phase 1b open-label study evaluating the preliminary safety and maximum tolerated dose of a new formulation of INNO-206 administered at doses of 230 mg/m2, 350 mg/m2 and 450 mg/m2 (165, 260, 325 mg/m2 doxorubicin equivalents, respectively) through intravenous infusion on Day 1 every 21 days for up to 6 cycles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18 and 70 years, male or female.\n* Histologically or cytologically confirmed malignant solid tumor that has relapsed or is refractory to standard therapy.\n* Subjects who have received prior radiation therapy with stable CNS metastasis with no progression of brain metastasis by CT/MRI scan in last 4 weeks.\n* Capable of providing informed consent and complying with trial procedures.\n* ECOG performance status 0-2.\n* Life expectancy \\>12 weeks.\n* Measurable or evaluable disease according to RECIST 1.1 criteria.\n* Women must not be able to become pregnant (e.g. post menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study.\n* Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.\n* Geographic accessibility to the site.\n\nExclusion Criteria:\n\n* Palliative surgery, chemotherapy, immunotherapy and/or radiation less than 4 weeks prior to the Screening Visit.\n* Exposure to any investigational agent within 30 days of the Screening Visit.\n* Laboratory values: Screening serum creatinine greater than or equal to 1.5 mg/dL, alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, total bilirubin greater than 3 times the upper limit of normal, white blood cell (WBC) count \\< 3500/mm3, absolute neutrophil count \\< 2000/mm3, platelet concentration \\< 100,000/mm3, hematocrit level \\< 33% for females or \\< 35% for males, or coagulation tests (PT,PTT) \\>1.5 times the upper limit or normal.\n* Clinically evident congestive heart failure \\> class II of the New York Heart Association (NYHA) guidelines.\n* Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.\n* History or signs of active coronary artery disease with or without angina pectoris.\n* Serious myocardial dysfunction defined scintigraphically (MUGA, myocardial scintigram)or ultrasound determined absolute left ventricular ejection fraction (LVEF) \\< 45% of predicted.\n* History of HIV infection.\n* Active, clinically significant serious infection requiring treatment with antibiotics, antivirals or antifungals.\n* Major surgery within 3 weeks prior to treatment.\n* Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.\n* Any condition that is unstable and could jeopardize the subject's participation in the study."}, 'identificationModule': {'nctId': 'NCT01337505', 'briefTitle': 'Safety and Maximum Tolerated Dose (MTD) Study of INNO-206 in Subjects With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'ImmunityBio, Inc.'}, 'officialTitle': 'An Open-Label Phase 1 Study to Investigate the Safety and Maximum Tolerated Dose of INNO-206 (Doxorubicin-6-Maleimidocaproyl Hydrazone; DOXO-EMCH) Administered as a 30 Minute Infusion Every 3 Weeks in Subjects With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'INNO-206-P1-MTD-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INNO-206', 'description': 'INNO-206 at dosages of 230, 350, and 450 mg/m2 doxorubicin equivalents of 165, 260, and 325 mg/m2)will be administered as a 30 minute IVI on Day 1 of each cycle.', 'interventionNames': ['Drug: INNO-206']}], 'interventions': [{'name': 'INNO-206', 'type': 'DRUG', 'otherNames': ['DOXO-EMCH'], 'description': 'INNO-206 at dosages of 230, 350, and 450 mg/m2 (doxorubicin equivalents of 165, 260, and 325 mg/m2) will be administered as a 30 minute IVI on Day 1 of each cycle.', 'armGroupLabels': ['INNO-206']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Sarcoma Oncology Center', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}], 'overallOfficials': [{'name': 'Sant Chawla, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sarcoma Oncology Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ImmunityBio, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}