Therapy Detail

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Therapy Name Sacituzumab govitecan-hziy
Synonyms
Therapy Description

Sacituzumab govitecan is an antibody-drug conjugate composed of a monoclonal anti-TROP2 antibody linked to the active metabolite of irinotecan (SN-38), which binds to TROP2 positive cancer cells and induces DNA breakage and apoptosis (PMID: 26541586).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Sacituzumab govitecan-hziy Trodelvy IMMU-132|Sactizumab Trodelvy (sacituzumab govitecan-hziy) is an antibody-drug conjugate composed of a monoclonal anti-TROP2 antibody linked to the active metabolite of irinotecan (SN-38), which binds to TROP2 positive cancer cells and induces DNA breakage and apoptosis (PMID: 26541586). Trodelvy (sacituzumab govitecan-hziy) is FDA approved for use in patients with metastatic triple-negative breast cancer who received two or more prior therapies, and in patients with locally advanced or metastatic urothelial cancer who received a platinum-containing chemotherapy and a PD-1 orPD-L1 inhibitor (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02574455 Phase III Sacituzumab govitecan-hziy Capecitabine + Eribulin + Gemcitabine + Vinorelbine ASCENT-Study of Sacituzumab Govitecan in Refractory/Relapsed Triple-Negative Breast Cancer (ASCENT) Completed USA | FRA | ESP | DEU | CAN | BEL 1
NCT03901339 Phase III Eribulin Gemcitabine Vinorelbine Capecitabine Sacituzumab govitecan-hziy Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 2
NCT04647916 Phase II Sacituzumab govitecan-hziy Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases Recruiting USA 0
NCT04527991 Phase III Paclitaxel Docetaxel Vinflunine Sacituzumab govitecan-hziy Study of Sacituzumab Govitecan (IMMU-132) in Metastatic or Locally Advanced Unresectable Urothelial Cancer (TROPiCS-04) Recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 17
NCT05332561 Phase II Olaparib Ipatasertib Sacituzumab govitecan-hziy GDC-0077 Pertuzumab/trastuzumab/hyaluronidase-zzxf Atezolizumab Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE) Not yet recruiting DEU 0
NCT04617522 Phase I Sacituzumab govitecan-hziy Study to Determine an Appropriate Starting Dose of Sacituzumab Govitecan-hziy in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment Recruiting USA 0
NCT04468061 Phase II Sacituzumab govitecan-hziy Pembrolizumab + Sacituzumab govitecan-hziy Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC Recruiting USA 0
NCT05382299 Phase III Nab-paclitaxel Carboplatin + Gemcitabine Sacituzumab govitecan-hziy Paclitaxel Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer (ASCENT-03) Recruiting USA 0
NCT04251416 Phase II Sacituzumab govitecan-hziy A Study of Sacituzumab Govitecan (IMMU-132) in Endometrial Carcinoma Recruiting USA 0
NCT03547973 Phase II Sacituzumab govitecan-hziy Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer Recruiting USA | FRA 0
NCT03995706 Phase I Sacituzumab govitecan-hziy Neuro/Sacituzumab Govitecan/Breast Brain Metastasis/Glioblastoma/Ph 0 Recruiting USA 0
NCT04230109 Phase II Sacituzumab govitecan-hziy Sacituzumab Govitecan In TNBC (NeoSTAR) Active, not recruiting USA 0
NCT05226117 Phase II Sacituzumab govitecan-hziy Sacituzumab Govitecan, Preceding Radical Cystectomy, in Treating Patients With Muscle-invasive Bladder Cancer Recruiting ITA 0
NCT03725761 Phase II Sacituzumab govitecan-hziy IMMU-132 in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy Recruiting USA 0
NCT04448886 Phase II Sacituzumab govitecan-hziy Pembrolizumab + Sacituzumab govitecan-hziy Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC Recruiting USA 0
NCT03964727 Phase II Sacituzumab govitecan-hziy A Study of Sacituzumab Govitecan in Metastatic Solid Tumors (Tropics-03) Recruiting USA | ESP 3
NCT05089734 Phase III Docetaxel Sacituzumab govitecan-hziy Study of Sacituzumab Govitecan-hziy (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-programmed Death Protein 1 (PD-1)/Programmed Death Ligand 1 (PD-L1) Immunotherapy (EVOKE-01) Recruiting USA | ITA | FRA | ESP | CAN | BEL | AUT 8


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