Therapy Detail

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Therapy Name Sacituzumab govitecan-hziy
Synonyms
Therapy Description

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, in patients with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies, and in patients with locally advanced or metastatic urothelial cancer who received a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Sacituzumab govitecan-hziy Trodelvy IMMU-132|Sactizumab|Sacituzumab govitecan TROP2 Antibody 7 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, in patients with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies, and in patients with locally advanced or metastatic urothelial cancer who received a platinum-containing chemotherapy and a PD-1 or PD-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
NCT04559230 Phase II Sacituzumab govitecan-hziy Sacituzumab Govitecan in Recurrent Glioblastoma Recruiting USA 0
NCT04230109 Phase II Sacituzumab govitecan-hziy Sacituzumab Govitecan In TNBC (NeoSTAR) Recruiting USA 0
NCT04579224 Phase III Sacituzumab govitecan-hziy Eribulin Gemcitabine Eribulin + Gemcitabine Docetaxel Paclitaxel Comparing the New Anti-cancer Drug Eribulin With or Without Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer 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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 21
NCT06178588 Phase II Sacituzumab govitecan-hziy Sacituzumab Govitecan for the Treatment for Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma Recruiting USA 0
NCT06123468 Phase Ib/II Sacituzumab govitecan-hziy Study Evaluating Treatment of Sacituzumab-govitecan for Patients With Metastatic Esophagogastric Adenocarcinoma Recruiting DEU | AUT 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 | FRA 0
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 | GBR | FRA | ESP | DEU | CAN | BEL 0
NCT06263543 Phase II Sacituzumab govitecan-hziy Sequencing Antibody Drug Conjugates in ER+/HER2 LOW MBC (SERIES) Not yet recruiting USA 0
NCT06161532 Phase II Atezolizumab + Sacituzumab govitecan-hziy Sacituzumab govitecan-hziy Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as Small Cell, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile Cancer Not yet 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) Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 17
NCT06248515 Phase II Sacituzumab govitecan-hziy A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors Recruiting USA 0
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) Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 9
NCT05838521 Phase II Sacituzumab govitecan-hziy A Study of Sacituzumab Govitecan (IMMU-132) in Patients With Recurrent or Persistent Cervical Cancer Recruiting USA 0
NCT05840211 Phase III Paclitaxel Capecitabine Nab-paclitaxel Sacituzumab govitecan-hziy Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy (ASCENT-07) Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 16
NCT03547973 Phase II Sacituzumab govitecan-hziy Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer Recruiting USA | ITA | GBR | FRA | ESP | DEU 3
NCT04595565 Phase III Sacituzumab govitecan-hziy Cisplatin Carboplatin Capecitabine Sacituzumab Govitecan in Primary HER2-negative Breast Cancer (SASCIA) Recruiting ITA | FRA | ESP | DEU | BEL | AUT 2
NCT04448886 Phase II Sacituzumab govitecan-hziy Pembrolizumab + Sacituzumab govitecan-hziy Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC Active, not recruiting USA 0
NCT04468061 Phase II Sacituzumab govitecan-hziy Pembrolizumab + Sacituzumab govitecan-hziy Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC Recruiting USA 0
NCT06312176 Phase III Paclitaxel Capecitabine Pegylated liposomal doxorubicin Nab-paclitaxel Sacituzumab govitecan-hziy Pembrolizumab + Sacituzumab govitecan-hziy A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010) Recruiting USA 2
NCT04647916 Phase II Sacituzumab govitecan-hziy Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases Recruiting USA 0
NCT06028932 Phase II Sacituzumab govitecan-hziy A Study of Sacituzumab Govitecan (IMMU-132) in Platinum-resistant Ovarian Cancer Patients Recruiting USA 0
NCT03995706 Phase I Sacituzumab govitecan-hziy Neuro/Sacituzumab Govitecan/Breast Brain Metastasis/Glioblastoma/Ph 0 Active, not recruiting USA 0
NCT03725761 Phase II Sacituzumab govitecan-hziy IMMU-132 in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy Active, not recruiting USA 0
NCT05884320 Phase II Sacituzumab govitecan-hziy Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Salivary Gland Cancers Recruiting USA 0
NCT06236269 Phase II Sacituzumab govitecan-hziy HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan (ACROSS-TROP2) Not yet recruiting ESP 0
NCT05226117 Phase II Sacituzumab govitecan-hziy Sacituzumab Govitecan, Preceding Radical Cystectomy, in Treating Patients With Muscle-invasive Bladder Cancer Unknown status ITA 0
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 (TROPiCS-02) Completed USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL 0
NCT03964727 Phase II Sacituzumab govitecan-hziy A Study of Sacituzumab Govitecan in Metastatic Solid Tumors (Tropics-03) Active, not recruiting USA | FRA | ESP | CAN | BEL | AUS 2
NCT06235216 Phase II Sacituzumab govitecan-hziy Sacituzumab govitEcan in THYroid Cancers (SETHY) Not yet recruiting ESP 0
NCT05581589 Phase II Sacituzumab govitecan-hziy Sacituzumab Govitecan Before Radical Cystectomy for the Treatment of Non-Urothelial Muscle Invasive Bladder Cancer Recruiting USA 0
NCT04251416 Phase II Sacituzumab govitecan-hziy A Study of Sacituzumab Govitecan (IMMU-132) in Endometrial Carcinoma Recruiting USA 0
NCT05552001 Phase III Sacituzumab govitecan-hziy Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer (ISIdE) Recruiting FRA 0
NCT05332561 Phase II Olaparib Ipatasertib Sacituzumab govitecan-hziy Inavolisib Pertuzumab/trastuzumab/hyaluronidase-zzxf Atezolizumab Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE) Recruiting DEU 0
NCT05633667 Phase II Etrumadenant + Sacituzumab govitecan-hziy + Zimberelimab Carboplatin + Paclitaxel + Zimberelimab Carboplatin + Nab-paclitaxel + Zimberelimab Docetaxel Etrumadenant + Zimberelimab Cisplatin + Pemetrexed Disodium + Zimberelimab Carboplatin + Pemetrexed Disodium + Zimberelimab AB154 + Sacituzumab govitecan-hziy + Zimberelimab AB154 + Etrumadenant + Zimberelimab Sacituzumab govitecan-hziy Study of Novel Treatment Combinations in Patients With Lung Cancer (VELOCITY-Lung) Recruiting USA | GBR 4
NCT05833867 Phase I Sacituzumab govitecan-hziy Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer Recruiting USA 0


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