Therapy Detail
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| Therapy Name | Sacituzumab govitecan-hziy |
| Synonyms | |
| Therapy Description |
Trodelvy (sacituzumab govitecan-hziy) is an antibody-drug conjugate (ADC) 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 13 | Trodelvy (sacituzumab govitecan-hziy) is an antibody-drug conjugate (ADC) 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 |
|---|---|---|---|---|---|---|
| NCT04647916 | Phase II | Sacituzumab govitecan-hziy | Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases | 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 |
| 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 | ROU | POL | NZL | NLD | ITA | ISR | HUN | GRC | GBR | FRA | ESP | CHE | CAN | BRA | BEL | AUS | ARG | 12 |
| NCT06178588 | Phase II | Sacituzumab govitecan-hziy | Sacituzumab Govitecan for the Treatment for Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma | 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) | Active, not recruiting | USA | POL | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG | 11 |
| NCT05833867 | Phase I | Sacituzumab govitecan-hziy | Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer | Recruiting | USA | 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 |
| 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 | TUR | SVK | ROU | POL | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG | 11 |
| NCT05226117 | Phase II | Sacituzumab govitecan-hziy | Sacituzumab Govitecan, Preceding Radical Cystectomy, in Treating Patients With Muscle-invasive Bladder Cancer | Unknown status | ITA | 0 |
| NCT03547973 | Phase II | Sacituzumab govitecan-hziy | Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer | Recruiting | USA | TUR | ITA | GRC | GBR | FRA | ESP | DEU | 1 |
| NCT04230109 | Phase II | Sacituzumab govitecan-hziy | Sacituzumab Govitecan In TNBC (NeoSTAR) | Recruiting | USA | 0 |
| NCT03995706 | Phase I | Sacituzumab govitecan-hziy | Neuro/Sacituzumab Govitecan/Breast Brain Metastasis/Glioblastoma/Ph 0 | Completed | USA | 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 |
| NCT05838521 | Phase II | Sacituzumab govitecan-hziy | A Study of Sacituzumab Govitecan (IMMU-132) in Patients With Recurrent or Persistent Cervical Cancer | Recruiting | USA | 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 |
| NCT04468061 | Phase II | Sacituzumab govitecan-hziy Pembrolizumab + Sacituzumab govitecan-hziy | Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC | Recruiting | USA | 0 |
| NCT06123468 | Phase Ib/II | Sacituzumab govitecan-hziy | Study Evaluating Treatment of Sacituzumab-govitecan for Patients With Metastatic Esophagogastric Adenocarcinoma | Active, not recruiting | DEU | AUT | 0 |
| NCT06263543 | Phase II | Sacituzumab govitecan-hziy | Sequencing Antibody Drug Conjugates in ER+/HER2 LOW MBC (SERIES) | Recruiting | USA | 0 |
| NCT06243393 | Phase II | Sacituzumab govitecan-hziy | Sacituzumab Govitecan in Metastatic Colorectal Cancer (TROPHIT1) | Recruiting | DEU | 0 |
| NCT06477419 | Phase II | Sacituzumab govitecan-hziy | A Study of Sacituzumab Govitecan in People With Mesothelioma | Recruiting | USA | 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 |
| NCT06409390 | Phase I | Fulvestrant + Ribociclib Trastuzumab deruxtecan Sacituzumab govitecan-hziy Capecitabine Abemaciclib + Fulvestrant Cyclophosphamide + Docetaxel + Sargramostim | Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer | Recruiting | USA | 0 |
| NCT04251416 | Phase II | Sacituzumab govitecan-hziy | A Study of Sacituzumab Govitecan (IMMU-132) in Endometrial Carcinoma | Recruiting | USA | 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 | ISR | GBR | BRA | 3 |
| 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 |
| 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 |
| 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 | TUR | POL | NLD | ITA | ISR | GRC | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUT | AUS | 4 |
| 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 |
| NCT04595565 | Phase III | Sacituzumab govitecan-hziy Cisplatin Carboplatin Capecitabine | Sacituzumab Govitecan in Primary HER2-negative Breast Cancer (SASCIA) | Active, not recruiting | IRL | FRA | ESP | DEU | CHE | BEL | AUT | 0 |
| NCT06235216 | Phase II | Sacituzumab govitecan-hziy | Sacituzumab govitEcan in THYroid Cancers (SETHY) | Recruiting | ESP | 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 | TUR | SWE | ITA | ISR | IRL | HRV | GRC | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BGR | BEL | AUT | AUS | 8 |
| 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 | Recruiting | USA | 0 |
| NCT04448886 | Phase II | Sacituzumab govitecan-hziy Pembrolizumab + Sacituzumab govitecan-hziy | Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC | Active, not recruiting | USA | 0 |
| NCT06236269 | Phase II | Sacituzumab govitecan-hziy | HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan (ACROSS-TROP2) | Recruiting | ESP | 0 |
| NCT04559230 | Phase II | Sacituzumab govitecan-hziy | Sacituzumab Govitecan in Recurrent Glioblastoma | 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 |
| NCT06028932 | Phase II | Sacituzumab govitecan-hziy | A Study of Sacituzumab Govitecan (IMMU-132) in Platinum-resistant Ovarian Cancer Patients | Recruiting | USA | 0 |
| NCT06486441 | Phase III | Doxorubicin Paclitaxel Sacituzumab govitecan-hziy | Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy (ASCENT-GYN-01/GOG-3104/ENGOT-en26) (ASCENT-GYN-01) | Recruiting | USA | 0 |
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