Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2025-12-24 @ 5:13 PM
Study NCT ID:
NCT03894150
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2019-03-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of F0002-ADC in Chinese Patients With Refractory or Recurrent CD30+ Hematologic Malignancies.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-12', 'studyFirstSubmitDate': '2019-03-26', 'studyFirstSubmitQcDate': '2019-03-27', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MTD', 'timeFrame': 'Within 21 days after a single dose', 'description': 'the maximum tolerable dose'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'Once every 2 cycles and once every 4 cycles after 4 cycles (each cycle is 21 days), till tumor progression/death /3 years', 'description': 'Objective response rate'}, {'measure': 'DOR', 'timeFrame': 'Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years', 'description': 'Duration of Response'}, {'measure': 'PFS', 'timeFrame': 'Once every 2 cycles and once every 4 cycles after 4 cycles(each cycle is 21 days), till tumor progression/death /3 years', 'description': 'Progress Free Survival'}, {'measure': 'Maximum Plasma Concentration [Cmax]', 'timeFrame': '1 months after last dose', 'description': 'pharmacokinetic parameter'}, {'measure': 'Area Under the Curve [AUC]', 'timeFrame': '1 months after last dose', 'description': 'pharmacokinetic parameter'}, {'measure': 'Tmax', 'timeFrame': '1 months after last dose', 'description': 'pharmacokinetic parameter'}, {'measure': 'Half-life Time [T1/2]', 'timeFrame': '1 months after last dose', 'description': 'pharmacokinetic parameter'}, {'measure': 'Clearance [CL]', 'timeFrame': '1 months after last dose', 'description': 'pharmacokinetic parameter'}, {'measure': 'Apparent Volume of Distribution [Vd]', 'timeFrame': '1 months after last dose', 'description': 'pharmacokinetic parameter'}, {'measure': 'Immunogenicity', 'timeFrame': '1 months after last dose', 'description': 'Anti-F0002-ADC Antibodies'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Till 1 month after last dose'}, {'measure': 'Incidence of laboratory abnormalities', 'timeFrame': 'Till 1 month after last dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Refractory or Recurrent CD30+ Hematologic Malignancies']}, 'descriptionModule': {'briefSummary': 'This is a Phase I dose escalation study designed to define the maximum tolerable dose(MDT), the safety profile, pharmacokinetic parameters, immunogenicity and anti-tumor activity of F0002-ADC in Chinese patients with relapsed/refractory CD30-positive hematologic malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* With relapsed/refractory CD30+ disease that histologically confirmed by central laboratory assessment and pathology review (Priority for cHL, ALCL and MF).\n* Patients must have at least one site of measurable disease by conventional CT scan (defined by unidimensional lymph node lesion ≥ 15 mm or extranodal lesion ≥ 10 mm ), patients with MF, skin nodules can be measured by caliper to meet the criteria as measurable lesions, positive FDG uptake for cHL and ALCL.\n* Patients must have the following required baseline laboratory data: Hb≥80g/L, NEUT≥1.5×109/L, PLT≥75×109/L, TBIL≤1.5 times ULN, ALT/AST≤2.5 times ULN, Cr≤1.25 times ULN or Ccr≥45 ml/min, INR≤1.5 times ULN, APTT≤1.5 times ULN.\n* Patients must be at least 8 weeks apart from the previous autologous stem cell infusion therapy prior to the first dose.\n* Patients must be at least 4 weeks apart from previous radiotherapy, chemotherapy, biologics, immunotherapy, and/or other research-based anticancer therapy prior to the first dose (with nitrogen mustard, melphalan, and nitrosourea for at least 6 weeks).\n* Patients must have a life expectancy \\> 3 months.\n* Voluntary consent form\n\nExclusion Criteria:\n\n* Patients who have received an allogeneic stem cell transplant.\n* Patients who have had previous treatment with any anti-CD30 antibody.\n* Patients received antibody therapy 6 weeks or 5 plasma half-life before the first dose.\n* Patients who are receiving other anti-tumor treatments.\n* The toxicity of previous anti-tumor treatment has not recovered to grade 1 or below, except for grade 2 peripheral neurotoxicity and any level of alopecia.\n* Other primary malignant tumors have been seen in the past 3 years (except for cervical cancer in situ or non-melanoma skin cancer or prostate cancer with specific prostate specific antigen).\n* Participants with cardiovascular conditions specified in protocols.\n* NYHA classification grading of cardiac function III/IV.\n* Participants with brain or meningeal disease conditions specified in protocols.\n* Patients with poor diabetes control,\n* High-risk participants with a history of \\> grade 2 peripheral neuropathy or any active neurologic disease.\n* Patients have psychiatric history.\n* Patients with a history of liver fibrosis or cirrhosis and clinical signs and symptoms suggesting liver fibrosis or cirrhosis.\n* Patients with previous interstitial pneumonia.\n* Patients have active systemic viral, bacterial or fungal infection 4 weeks prior to the first dose\n* HIV antibody positive / HBsAg positive / HCVAb positive.\n* Patients who are allergic to recombinant proteins, murine proteins or to the drug excipients.\n* Patients who are receiving a dose ≥ 20 mg/day of prednisone or glucocorticoid therapy.\n* Female patients who are breastfeeding or pregnant.\n* Patients with fertility who refuses to use contraception during the trial period and within 6 months after the end of the last dose.\n* Other reasons that researchers believe are inappropriate to participate in this study.'}, 'identificationModule': {'nctId': 'NCT03894150', 'briefTitle': 'A Study of F0002-ADC in Chinese Patients With Refractory or Recurrent CD30+ Hematologic Malignancies.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of F0002-ADC in Chinese Patients With Refractory or Recurrent CD30+ Hematologic Malignancies.', 'orgStudyIdInfo': {'id': 'F0002-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'F0002-ADC', 'interventionNames': ['Drug: F0002-ADC']}], 'interventions': [{'name': 'F0002-ADC', 'type': 'DRUG', 'description': 'Every 21 days for 1 cycle, continue treatment until a maximum 16 cycles. Dose Escalating: 0.3 - 4.8 mg/kg', 'armGroupLabels': ['F0002-ADC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '450008', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}