Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 3:06 AM
Study NCT ID:
NCT07439120
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability Study of 68Ga/177Lu-BRP-020063 in Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-11', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'ORR', 'timeFrame': 'be assessed at 6-week or 8-week intervals from the start of treatment until disease progression to up to 1 year.'}, {'measure': 'DCR', 'timeFrame': 'be assessed at 6-week or 8-week intervals from the start of treatment until disease progression to up to 1 year.'}], 'primaryOutcomes': [{'measure': 'Adeverse Events', 'timeFrame': 'From enrolment to 4 weeks after the first dose'}], 'secondaryOutcomes': [{'measure': 'PK Parameters', 'timeFrame': 'From administration up to 168 hours post-dose', 'description': 'AUC(0-∞)'}, {'measure': 'Biodistribution', 'timeFrame': 'From administration up to 168 hours post-dose', 'description': 'Perform whole-body SPECT/CT to determine radioactivity (%ID) in major organs over time for biodistribution assessment.'}, {'measure': 'Radiation Dosimetry', 'timeFrame': 'from administration up to 168 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urothelial Carcinoma (UC)']}, 'descriptionModule': {'briefSummary': 'This study is an open-label, single-arm, interventional clinical trial designed to investigate the safety of ⁶⁸Ga/¹⁷⁷Lu-BRP-020063 in patients with advanced metastatic solid tumors; to evaluate the pharmacokinetics, biodistribution, and radiation dosimetry of ¹⁷⁷Lu-BRP-020063 in patients with metastatic solid tumors; and to preliminarily explore its therapeutic efficacy. The study plans to enroll 10 patients to receive ⁶⁸Ga-BRP-020063 PET/CT imaging, among whom 5 patients positive for ⁶⁸Ga-BRP-020063 will be selected to receive a low dose of ¹⁷⁷Lu-BRP-020063. The results of this study will provide a basis for the design of subsequent studies involving higher doses of ¹⁷⁷Lu-BRP-020063.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years, regardless of gender;\n2. Patients with a confirmed diagnosis of advanced metastatic solid tumor (preferably urothelial carcinoma, followed by breast cancer);\n3. Willing to provide archived or freshly biopsied tumor tissue specimens (recommended within the past 2 years);\n4. Performance status (ECOG) score of 0-1;\n5. Adequate organ function:\n\n * Complete Blood Count: White blood cell count ≥ 3.0 × 10⁹/L, neutrophil count ≥ 1.5 × 10⁹/L, hemoglobin ≥ 90 g/L, platelet count ≥ 75 × 10⁹/L;\n * Liver function: Total bilirubin ≤ 2.5 × ULN, alanine aminotransferase ≤ 3 × ULN, aspartate aminotransferase ≤ 3 × ULN;\n * Renal function: Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula);\n * Coagulation function: Prothrombin time ≤ 1.5 × ULN, activated partial thromboplastin time ≤ 1.5 × ULN, international normalized ratio ≤ 1.5 × ULN;\n6. Subjects of childbearing potential must voluntarily adopt effective contraception during the treatment period and for 6 months after the last dose of the investigational drug (for females);\n7. Willing to participate in this trial and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Previous treatment with Nectin-4-targeted drugs (including clinical trials);\n2. Inability to complete PET/CT or SPECT/CT examinations (including inability to lie flat, claustrophobia, radiophobia, etc.);\n3. Participation in drug or device clinical studies within 4 weeks prior to the first dose;\n4. Presence of severe or uncontrolled underlying diseases, including but not limited to:\n\n 1. NYHA Class II or higher congestive heart failure, or severe arrhythmia requiring medication;\n 2. Severe cardiovascular/cerebrovascular or valvular diseases;\n 3. Poorly controlled diabetes or hypertension;\n5. Inability to tolerate intravenous administration or difficulty with venipuncture (e.g., history of needle or blood phobia);\n6. Active infection within 4 weeks prior to the first dose;\n7. Women who are planning pregnancy, currently pregnant, or breastfeeding;\n8. Allergy to radioactive rays or other severe allergic history;\n9. History of neurological metastasis with associated symptoms;\n10. Concurrent other malignancies;\n11. Undergone general anesthesia surgery within 4 weeks prior to the first dose;\n12. Other conditions deemed by the investigator as unsuitable for inclusion in the clinical study.'}, 'identificationModule': {'nctId': 'NCT07439120', 'briefTitle': 'Safety and Tolerability Study of 68Ga/177Lu-BRP-020063 in Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'A Study Evaluating the Safety, Pharmacokinetics, and Radiation Dosimetry of 68Ga/177Lu-BRP-020063 in Patients With Advanced Metastatic Solid Tumors.', 'orgStudyIdInfo': {'id': 'IIT-2026-030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '⁶⁸Ga/¹⁷⁷Lu-BRP-020063 Treatment Arm', 'interventionNames': ['Drug: ⁶⁸Ga/¹⁷⁷Lu-BRP-020063']}], 'interventions': [{'name': '⁶⁸Ga/¹⁷⁷Lu-BRP-020063', 'type': 'DRUG', 'description': '68Ga-BRP-020063 Injection (Diagnostic Phase): All subjects will receive a single administration of 68Ga-BRP-020063 injection. The dose of 5 mCi (185 MBq), within an acceptable range of 3-7 mCi (111-259 MBq), will be delivered via rapid consecutive intravenous bolus injection in a volume not exceeding 10 mL, followed by a saline flush.\n\n177Lu-BRP-020063 Injection (Therapeutic Phase): Five subjects who show positive results on the 68Ga-BRP-020063 PET/CT scan will be selected to receive a single administration of 177Lu-BRP-020063 injection. A dose of 40 mCi (1.48 GBq), within an acceptable range of 30-50 mCi (1.11-1.85 GBq), will be administered via intravenous infusion over approximately 20 minutes using an infusion pump, followed by a saline flush.', 'armGroupLabels': ['⁶⁸Ga/¹⁷⁷Lu-BRP-020063 Treatment Arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yan Xing, Dr.', 'role': 'CONTACT', 'email': 'xy.1@163.com', 'phone': '+862163246311'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Yan Xing', 'investigatorAffiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}}}}