[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604780":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":41,"collaborators":11,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":11,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":11,"enrollmentInfo":52,"targetDuration":11,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":11,"overallStatus":62,"whyStopped":11,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"sac-TMT plus Tagitanlimab","EXPERIMENTAL",null,[13],"Drug: Sacituzumab Tirumotecan plus Tagitanlimab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Sacituzumab Tirumotecan plus Tagitanlimab","Sacituzumab Tirumotecan 5mg\u002Fkg intravenously (IV) infusion every 2 weeks on Day 1, Tagitanlimab 900mg IV every 2 weeks on Day 1, until disease progression, unacceptable toxic effects, withdrawal from the trial, or death, whichever occurred first.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Yehui Shi","CONTACT","86+18622221183","shiyehui@tjmuch.com",[27],{"facility":5,"status":11,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Tianjin","Tianjin Municipality","30000","China","CN",{"type":34,"coordinates":35},"Point",[36,37],117.17667,39.14222,{"lat":37,"lon":36},[40],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},{"type":42,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100604780","phase-2-sacituzumab-tirumotecan-plus-tagitanlimab-in-previously-treated-locally-advanced-or-metastatic-triple-negative-breast-cancer-100604780",false,"NCT07153965","Sacituzumab Tirumotecan Plus Tagitanlimab in Previously Treated Locally Advanced or Metastatic Triple Negative Breast Cancer","An Open-label, Single-arm, Multicenter Phase II Study of Sacituzumab Tirumotecan (Sac-TMT) Plus Tagitanlimab in Previously Treated PD-L1-positive Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)","Key inclusion criteria include but are not limited to:\n\n* Age ≥ 18 years at the time of signing informed consent.\n* Histologically and\u002For cytologically confirmed triple-negative breast cancer (TNBC) based on the most recent biopsy or other pathological specimens, including:\n\n  1. Definition of human epidermal growth factor receptor 2 (HER2) negative: immunohistochemistry (IHC) of 0 or 1+; if HER2 is 2+ by IHC, negative HER2 expression must be confirmed by fluorescencein situ hybridization (FISH); Estrogen and progesterone receptor negative means that less than 1% of the cells express hormone receptors as indicated by IHC.\n  2. Tumor stage: locally advanced, recurrent, or metastatic TNBC; locally advanced cases must be confirmed by the investigator as unsuitable for curative surgical resection.\n* Patients with unresectable locally advanced or metastatic triple-negative breast cancer:\n\n  1. Those who have received chemotherapy combined with a PD-(L)1 inhibitor as first-line treatment for locally advanced or metastatic disease and experienced progression ≥ 3 months later.\n  2. Those who received chemotherapy combined with a PD-(L)1 inhibitor in the neoadjuvant and\u002For adjuvant setting and experienced recurrence or disease progression to unresectable locally advanced or metastatic disease ≥ 3 months later but within 12 months.\n  3. Those who received chemotherapy combined with a PD-(L)1 inhibitor in the neoadjuvant and\u002For adjuvant setting and experienced recurrence or disease progression to unresectable locally advanced or metastatic disease after ≥ 12 months, and have subsequently progressed on first-line treatment for locally advanced or metastatic disease.\n* Newly diagnosed brain metastases at screening must be stable for ≥ 4weeks after local treatment (e.g., radiotherapy) with imaging confirmation.\n* The most recent tumor tissue sample from the primary and\u002For metastatic lesion must show a PD-L1 combined positive score (CPS) ≥ 1.\n* Patients must have at least one measurable lesion per RECIST v1.1 criteria; those with only skin or bone lesions cannot be included.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to1.\n* Patients must have adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin, or colony stimulating factor therapy has been received within 2 weeks prior to the treatment)\n* Patients of childbearing potential (male or female) must use effective medical contraception from consent until 6 months after the end of the dosing period.\n\nKey exclusion criteria include but are not limited to:\n\n* Previously received any of the following treatments (including in the adjuvant or neoadjuvant setting):\n\n  1. Targeted TROP2 therapy.\n  2. Any drug treatment targeting topoisomerase I, including antibody drug conjugates (ADC) therapy.\n* Known to have meningeal metastasis, brainstem metastasis, spinalcord metastasis, and\u002For compression, active central nervous system(CNS) metastasis. Patients with previously treated brain metastases canparticipate if clinically stable for at least 4 weeks before dosing and do not require corticosteroids or anticonvulsants for at least 14 days. Patients with untreated asymptomatic brain metastases must require investigator approval.\n* Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or corneal disease that prevents\u002Fdelays corneal healing.\n* Within 3 years before administration having other malignancies (except forthose cured by local treatment, such as basal cell carcinoma of the skin,squamous cell carcinoma of the skin, cervical carcinoma in situ, etc.).\n* Has uncontrolled, significant cardiovascular disease or risk factors, uncontrollable systemic diseases.\n* Presence of steroid-requiring (non-infectious) interstitial lung disease (ILD)or a history of non-infectious pneumonia, currently having ILD or non-infectious pneumonia, or suspected ILD or non-infectious pneumonia that cannot be ruled out by imaging at screening.\n* Unresolved toxicities from previous anti-tumor therapy to ≤ Grade 1 (based on NCI CTCAE v5.0) or the level specified in the inclusion and exclusion criteria.\n* Patients with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcers, gastrointestinal perforation, abdominal abscess, or acute gastrointestinal bleeding.\n* Having an active autoimmune disease requiring systemic treatment inthe past two years.\n* Known active tuberculosis, hepatitis B or hepatitis C.\n* Human Immunodeficiency Virus (HIV) test positive or history of Acquired Immunodeficiency Syndrome (AIDS); known active syphilis infection.\n* Known allergy to the study drug or any of its components, known history of severe hypersensitivity to other biological products\n* Pregnant or breastfeeding women.","ALL","18 Years",{"count":53,"type":54},47,"ESTIMATED","INTERVENTIONAL",[57],"PHASE2","This is an open-label, single-arm, multicenter phase II study to evaluate the safety and efficacy of sac-TMT plus Tagitanlimab in patients with PD-L1-positive locally advanced or metastatic TNBC.",[60,61],"Triple Negative Breast Cancer (TNBC)","PD-L1 Positive","NOT_YET_RECRUITING","2025-08-31",{"date":65,"type":66},"2025-09-04","ACTUAL",{"date":68,"type":54},"2025-09-01",{"date":70,"type":54},"2027-09-01",{"name":5,"class":6},1]