Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-05 @ 5:59 AM
Study NCT ID:
NCT07093866
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2025-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer：a Phase II Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722994', 'term': 'disitamab vedotin'}, {'id': 'C000720858', 'term': 'RC48 antibody'}, {'id': 'C089740', 'term': 'abiraterone'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Experimental regimen: Disitamab vedotin +Abiraterone +Prednisone'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2025-07-22', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PSA 50', 'timeFrame': 'baseline up to 24 weeks', 'description': 'Proportion of patients with a ≥50 % prostate-specific antigen (PSA) reduction from baseline at Week 12, confirmed by a repeat assessment at least 3 weeks later.'}], 'secondaryOutcomes': [{'measure': 'PSA 30', 'timeFrame': 'baseline up to 24 weeks', 'description': 'Proportion of patients with a ≥30 % prostate-specific antigen (PSA) reduction from baseline at Week 12, confirmed by a repeat assessment at least 3 weeks later.'}, {'measure': 'PSA 90', 'timeFrame': 'baseline up to 24 weeks', 'description': 'Proportion of patients with a ≥90 % prostate-specific antigen (PSA) reduction from baseline at Week 12, confirmed by a repeat assessment at least 3 weeks later.'}, {'measure': 'Radiographic Progression-Free Survival（rPFS）', 'timeFrame': 'From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months', 'description': 'Time from the first day of study drug administration to the earlier of radiographic progression or death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mCRPC'], 'conditions': ['mCRPC']}, 'descriptionModule': {'briefSummary': 'This is an open-label，prospective，single-arm，phase 2 trial aims to evaluate the efficacy and safety of disitamab vedotin combined with abiraterone in patients with metastatic castration-resistant prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients are able to understand and voluntarily sign the informed consent form (ICF); judged by the investigator to be capable of complying with the protocol.\n* Male patients of ≥18 years or older at the time of ICF signature.\n* Patients with ECOG performance status 0-1.\n* Patients with an expected survival of 3months or more.\n* Patients who are histologically or cytologically confirmed prostatic adenocarcinoma with HER2 expression (IHC 1+, 2+ or 3+) in archival or fresh tumour tissue.\n* Patients with documented castration-resistant prostate cancer (CRPC): serum testosterone \\<1.73 nmol/L (50 ng/dL) at screening; patients on medical castration must continue LHRH agonist/antagonist therapy throughout the study.\n* Patients with evidence of metastatic disease by bone scan (bone lesions) and/or CT/MRI (soft-tissue lesions).\n* Patients with adequate organ function as defined below:\n\n * Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L\n * Platelet count (PLT) ≥100 × 10⁹/L\n * Hemoglobin (Hb) ≥100 g/L\n * Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); ≤2 × ULN if liver metastases present\n * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN; ≤2 × ULN if liver metastases present\n * Serum creatinine (Cr) ≤1.5 × ULN or calculated creatinine clearance (CrCl) ≥60 mL/min (Cockcroft-Gault formula; calculate only if Cr \\>1.5 × ULN)\n * Urinalysis protein \\<2+; if ≥2+, 24-h urine protein must be \\<1 g or urine protein/creatinine ratio \\<0.5\n * For patients not on anticoagulation: INR and aPTT ≤1.5 × ULN; patients on stable-dose anticoagulation are eligible\n * Left ventricular ejection fraction (LVEF) ≥50% or ≥local lower limit of normal (LLN), whichever is lower\n * QTcF interval \\<470 ms\n* Male patients with partners of child-bearing potential must use a medically acceptable contraceptive method from the first study dose until 3 months after the last dose.\n\nExclusion Criteria:\n\n* Patients who are known hypersensitivity to any component of disitamab vedotin or abiraterone.\n* Patients with other malignancies within 3 years before screening, except early-stage malignancies considered clinically cured (carcinoma in situ or stage I tumors), e.g., basal-cell or squamous-cell skin carcinoma or superficial bladder cancer.\n* Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with treated brain metastases may enroll if lesions have been stable for ≥1 month, there is no evidence of new or enlarging CNS disease, and systemic corticosteroids have been discontinued ≥3 days before the first study dose.\n* Patients who are clinically significant pericardial effusion, or pleural/peritoneal/pelvic effusions that are poorly controlled or require drainage within 2 weeks before the first dose.\n* Patients with major surgical intervention (any grade 3 or 4 procedure per the 2009 Chinese Regulation on Clinical Application of Medical Technologies) within 4 weeks before the first dose, or incomplete post-operative recovery that, in the investigator's judgment, poses a risk to trial participation.\n* Patients who are prior PSMA-targeted therapy.\n* Patients within 4 weeks (6 weeks for nitrosoureas or mitomycin C) before the first dose: any antineoplastic chemotherapy (except castration therapy), radiotherapy (\\>1 week of local palliative radiotherapy permitted), endocrine therapy (estrogens or anti-androgens; bicalutamide or nilutamide require 6-week washout), targeted therapy, immunotherapy, or participation in another interventional clinical trial (observational studies or post-trial follow-up are allowed).\n\n * Patients with stable-dose denosumab or bisphosphonates for bone metastases are permitted.\n * mCRPC patients must not have used PSA-lowering herbal agents (e.g., saw palmetto) or systemic corticosteroids (except short courses for allergy prophylaxis/treatment) within 4 weeks before the first dose, nor plan to use such agents during the study.\n* Patients with use of antineoplastic traditional Chinese medicine (TCM) prescriptions or proprietary TCM within 1 week, or receipt of blood transfusion/blood products, hematopoietic growth factors, or other agents to correct blood cell counts within 2 weeks before first study dose.\n* Patients with toxicities from prior antineoplastic therapy that have not resolved to baseline, CTCAE v5.0 grade 0-1 (except alopecia and pigmentation), or to the levels specified in the inclusion/exclusion criteria; unhealed wounds. Irreversible toxicities not expected to worsen with study drug (e.g., hearing loss) are permitted.\n* Patients with unexplained fever \\>38.5 °C (tumor-related fever may be allowed per investigator judgment); active or persistent infection; HIV antibody positive; HBsAg positive with HBV DNA \\> site ULN, or HBsAg-negative/HBcAb-positive with HBV DNA \\> site ULN after treatment; HCV antibody positive with HCV RNA \\> site ULN; active syphilis (except adequately treated, cured, or stable syphilis).\n* NYHA class III/IV congestive heart failure; uncontrolled arrhythmia despite treatment/intervention; risk of QT prolongation or use of drugs known to prolong QT; refractory hypertension (hypertension controlled to \\<140/90 mmHg on medication is allowed).\n* Patients with clinically significant vascular events within 6 months before first dose, including acute arterial/venous thromboembolism, thrombotic arteritis, thrombophlebitis, acute pulmonary embolism, acute coronary syndrome (MI, unstable angina, etc.), acute cerebrovascular events, or disseminated intravascular coagulation.\n* Patients with tumor metastases with clear invasion of major arteries posing a high bleeding risk.\n* Patients with interstitial pneumonitis, pulmonary fibrosis, or other severe pulmonary disease requiring treatment; hemoptysis \\>2.5 mL per episode within 3 weeks before first dose.\n* Patients with active gastro-intestinal ulcer, perforation, and/or fistula requiring treatment within 6 months; GI bleeding (hematemesis, melena, or hematochezia) within 3 months without endoscopic/colonoscopic evidence of complete healing.\n* Patients with uncontrolled concurrent disease \\>CTCAE v5.0 grade 2 (e.g., diabetes).\n\nUncontrolled concurrent disease \\>CTCAE v5.0 grade 2 (e.g., diabetes).\n\n* Patients with CTCAE v5.0 grade \\>2 peripheral neuropathy, prior epilepsy, psychiatric disorders; history of drug abuse within 6 months or alcohol abuse within 3 months (alcohol abuse defined as \\>14 units/week: 1 unit = 285 mL beer, 25 mL spirits, or 80 mL wine).\n* Patients with autoimmune disease, immunodeficiency, or organ transplantation.\n* Patients with any condition, therapy, or laboratory abnormality that, in the investigator's opinion, could confound results, interfere with trial participation, or be not in the subject's best interest."}, 'identificationModule': {'nctId': 'NCT07093866', 'briefTitle': 'Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer：a Phase II Study', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer：a Phase II Study', 'orgStudyIdInfo': {'id': 'IUNU-PC-125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'mCRPC subjects with IHC 1+/IHC 2+/IHC3+ are administered Disitamab Vedotin combined with Abiraterone', 'interventionNames': ['Drug: Disitamab Vedotin (RC48)', 'Drug: Abiraterone + prednisone']}], 'interventions': [{'name': 'Disitamab Vedotin (RC48)', 'type': 'DRUG', 'description': 'Disitamab Vedotin 2mg/kg is administered intravenously once every 2 weeks (1 cycle)', 'armGroupLabels': ['Arm A']}, {'name': 'Abiraterone + prednisone', 'type': 'DRUG', 'description': 'Abiraterone 1000mg is administered orally once a day，and prednisone 5mg is administered orally twice a day.', 'armGroupLabels': ['Arm A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongqian Guo Hongqian Guo, PhD', 'role': 'CONTACT', 'email': 'dr.ghq@nju.edu.cn', 'phone': '8613605171690'}], 'facility': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu 210000', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Hongqian Guo Hong qian Guo', 'role': 'CONTACT', 'email': 'gymwpi@126.com', 'phone': '8613605171690'}, {'name': 'Shun Zhang Shun Zhang', 'role': 'CONTACT', 'email': 'gymwgcp@126.com', 'phone': '8615050589789'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nanjing University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Hongqian Guo', 'investigatorAffiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}}}}