[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593839":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":53,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":21,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":21,"enrollmentInfo":68,"targetDuration":21,"studyType":71,"phases":72,"briefSummary":75,"conditions":76,"keywords":21,"overallStatus":38,"whyStopped":21,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment with Naxitamab and Sacituzumab Govitecan IV Q3W","EXPERIMENTAL","Patients receive naxitamab IV on days 2, 4, and 6 of cycles 1-8 and sacituzumab govitecan IV days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.",[13,14],"Drug: Sacituzumab govitecan","Drug: Naxitamab",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Sacituzumab govitecan","Given by IV",[9],null,{"type":17,"name":23,"description":19,"armGroupLabels":24,"otherNames":21},"Naxitamab",[9],[26],{"name":27,"affiliation":5,"role":28},"Clinton Yam, MD","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":21,"email":34},"Akshara S Raghavendra","CONTACT","713-792-2817","TNBC-NOW@mdanderson.org",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"The University of Texas M. D. Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-95.36327,29.76328,{"lat":48,"lon":47},[51,52],{"name":27,"role":32,"phone":33,"phoneExt":21,"email":34},{"name":27,"role":28,"phone":21,"phoneExt":21,"email":21},{"type":54,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[56],{"name":57,"class":58},"Y-mAbs Therapeutics","INDUSTRY","100593839","phase-1-study-of-naxitamab-and-sacituzumab-govitecan-in-patients-with-metastatic-triple-negative-breast-cancer-tnbc-100593839",false,"NCT07011654","Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)","Phase I\u002FII Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)","Inclusion criteria\n\n* Male and female participants aged 18 years or older and able to understand and give written informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (for the phase I portion of the study) and ECOG performance status of 0-2 (for the phase II portion of the study)\n* Life expectancy of at least 3 months\n* Histologically confirmed metastatic TNBC. (Estrogen receptor \\[ER\\] ≤10%; Progesterone receptor \\[PgR\\] ≤10%, HER2-negative as per ASCO\u002FCAP guidelines)\n* Willingness to provide archival tumor tissue for correlative studies associated with this trial.\n* Received at least 1 prior line of systemic chemotherapy for metastatic TNBC and\u002For meet criteria to receive sacituzumab govitecan as standard of care\n* Measurable disease by CT or MRI as per RECIST Version 1.1 criteria\n* Adequate organ and marrow function as defined below:\n\n  2\\. Exclusion Criteria Participants who meet any of the following exclusion criteria are not eligible to be enrolled in this study.\n* Positive serum pregnancy test or women who are lactating.\n* Known or severe (≥ Grade 3) hypersensitivity or allergy to naxitamab and\u002For sacituzumab govitecan, their metabolites, or formulation excipient.\n* Grade 3 or greater peripheral neuropathy\n* Have previously received treatment with an anti-GD2 antibody\n* Prior treatment with TROP2-targeting antibody drug conjugates in the metastatic setting. Participant s who have received TROP2-targeting antibody drug conjugates in the neoadjuvant setting or adjuvant setting are eligible if at least 6 months have elapsed since the last dose of TROP2-targeting antibody drug conjugate.\n* Have an active second malignancy. Participant s with a history of active cancer for 3 years prior to enrollment, or participant s with surgically cured tumors with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll.\n* Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Have undergone an allogenic tissue or solid organ transplant.\n* Uncontrolled hypertension, defined as a consistently elevated systolic blood pressure of \\>160 mmHg despite optimal medical management\n* Clinically significant cardiac disease\n* Inadequate pulmonary function\n* Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment.\n* Uncontrolled seizure disorders despite anticonvulsant therapy (defined as a seizure event within 3 months prior to enrollment)\n* Active serious infection requiring systemic antimicrobial therapy.\n* Participants positive for HIV-1 or 2 with a history of Kaposi sarcoma and\u002For Multicentric Castleman Disease.\n* Have active hepatitis B or C infection\n* Has a diagnosis of immunodeficiency or receiving systemic corticosteroid therapy (higher than physiologic doses) ≥ 10 mg of prednisone per day or equivalent\\] or any other form of immunosuppressive therapy within 14 days of initiation of study treatment.\n* Has received prior radiotherapy within 1 weeks of start of study intervention.","ALL","18 Years",{"count":69,"type":70},31,"ESTIMATED","INTERVENTIONAL",[73,74],"PHASE1","PHASE2","This phase I\u002FII trial tests the safety, best dose, and effectiveness of naxitamab in combination with sacituzumab govitecan in treating patients with triple-negative breast cancer (TNBC) that has spread from where it first started (primary site) to other places in the body (metastatic).",[77],"Metastatic Triple-Negative Breast Cancer","2026-05-18",{"date":80,"type":81},"2026-05-20","ACTUAL",{"date":83,"type":81},"2025-09-19",{"date":85,"type":70},"2030-07-01",{"name":5,"class":6},1]