Sacituzumab Govitecan

Summary

Sacituzumab Govitecan (CHEMBL3545262) is an approved antibody drug conjugate (ATC L01FX17) targeting TACSTD2; indicated across 27 conditions including triple-negative breast carcinoma and breast neoplasm; with CIViC clinical evidence for 3 variant-indication associations (e.g. TACSTD2 T256R in triple-receptor negative breast cancer).

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody drug conjugate
• ATC class: L01FX17
• Targets: 1 (TACSTD2)
• Indications: 27 conditions
• Clinical trials: 104
• Precision-oncology evidence (CIViC): 3 variant–indication associations

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3545262
Name	Sacituzumab Govitecan
Type	Antibody drug conjugate
Max phase	4
ATC	L01FX17

Also known as: HRS7SN38, IMMU-132, Sacituzumab govitecan, Sacituzumab govitecan hziy, Sacituzumab govitecan-hziy, Trodelvy, SACITUZUMAB GOVITECAN

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
TACSTD2	tumor associated calcium signal transducer 2	Binding	9.54	0.7%	P09758

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): TACSTD2.

Dominant GO biological processes

GO term	Targets
visual perception	1
negative regulation of epithelial cell migration	1
regulation of epithelial cell proliferation	1
negative regulation of stress fiber assembly	1
ureteric bud morphogenesis	1
negative regulation of branching involved in ureteric bud morphogenesis	1
negative regulation of substrate adhesion-dependent cell spreading	1
negative regulation of ruffle assembly	1
negative regulation of cell motility	1
positive regulation of stem cell differentiation	1

Indications & clinical

Indications

6 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
triple-negative breast carcinoma	4	MONDO:0005494	EFO:0005537
breast neoplasm	4	MONDO:0021100	MONDO:0007254
neoplasm	4	MONDO:0005070	EFO:0000616
endometrial carcinoma	3	MONDO:0002447	EFO:1001512
non-small cell lung carcinoma	3	MONDO:0005233	EFO:0003060
endometrium neoplasm	3	MONDO:0021251	MONDO:0011962

12 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
glioblastoma	2	MONDO:0018177	EFO:0000519
urothelial carcinoma	2	MONDO:0040679	EFO:0008528
mesothelioma	2	MONDO:0005065	EFO:0000588
ovarian carcinoma	2	MONDO:0005140	EFO:0001075
brain disorder	2	MONDO:0005560	EFO:0005774
esophageal squamous cell carcinoma	2	MONDO:0005580	EFO:0005922
thymic carcinoma	2	MONDO:0006451	EFO:1000576
thymoma	2	MONDO:0006456	EFO:1000581
hilar cholangiocarcinoma	2	MONDO:0003345	EFO:1001959
lung neoplasm	2	MONDO:0021117	MONDO:0008903
small cell lung carcinoma	1	MONDO:0008433	EFO:0000702
gastric adenocarcinoma	1	MONDO:0005036	EFO:0000503

9 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 104.

Phase distribution

Phase	Trials
PHASE2	57
PHASE3	18
PHASE1/PHASE2	18
PHASE1	7
Not specified	3
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT04579224	PHASE3	ACTIVE_NOT_RECRUITING	Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer
NCT04595565	PHASE3	ACTIVE_NOT_RECRUITING	Sacituzumab Govitecan in Primary HER2-negative Breast Cancer
NCT04639986	PHASE3	ACTIVE_NOT_RECRUITING	Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)
NCT05382286	PHASE3	ACTIVE_NOT_RECRUITING	Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
NCT05382299	PHASE3	ACTIVE_NOT_RECRUITING	Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician’s Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
NCT05552001	PHASE3	RECRUITING	Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer
NCT05609968	PHASE3	ACTIVE_NOT_RECRUITING	Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)
NCT05840211	PHASE3	ACTIVE_NOT_RECRUITING	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
NCT06081244	PHASE3	RECRUITING	NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)
NCT06431633	PHASE3	RECRUITING	Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously Operated on Who Were Not Disease-free.
NCT06486441	PHASE3	ACTIVE_NOT_RECRUITING	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)
NCT06524544	PHASE3	RECRUITING	A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitean-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer
NCT07178730	PHASE3	NOT_YET_RECRUITING	NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer
NCT07461454	PHASE3	RECRUITING	YL202 Versus Treatment of Physician’s Choice in Patients With HR+/HER2- Breast Cancer
NCT07533123	PHASE3	RECRUITING	A Phase III Study of JSKN016 Versus Treatment of Physician’s Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care
NCT02574455	PHASE3	COMPLETED	Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)
NCT03901339	PHASE3	COMPLETED	Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician’s Choice in Participants With HR+/HER2- Metastatic Breast Cancer
NCT04527991	PHASE3	COMPLETED	Study of Sacituzumab Govitecan Versus Physician’s Choice of Treatment in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
NCT03424005	PHASE1/PHASE2	RECRUITING	A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
NCT03547973	PHASE2	RECRUITING	Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
NCT03606967	PHASE2	RECRUITING	Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
NCT03725761	PHASE2	ACTIVE_NOT_RECRUITING	Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy
NCT03964727	PHASE2	ACTIVE_NOT_RECRUITING	Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors
NCT03971409	PHASE2	ACTIVE_NOT_RECRUITING	Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer
NCT04039230	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	Study to Evaluate Sacituzumab Govitecan in Combination With Talazoparib in Patients With Metastatic Breast Cancer.
NCT04230109	PHASE2	RECRUITING	Sacituzumab Govitecan In TNBC
NCT04251416	PHASE2	ACTIVE_NOT_RECRUITING	A Study of Sacituzumab Govitecan (IMMU-132) in Endometrial Carcinoma
NCT04434040	PHASE2	RECRUITING	Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)
NCT04448886	PHASE2	ACTIVE_NOT_RECRUITING	Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
NCT04454437	PHASE2	ACTIVE_NOT_RECRUITING	Study of Sacituzumab Govitecan in Chinese Patients With Metastatic Triple-negative Breast Cancer Who Received at Least Two Prior Treatments
NCT04468061	PHASE2	RECRUITING	Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC
NCT04559230	PHASE2	RECRUITING	Sacituzumab Govitecan in Recurrent Glioblastoma
NCT04647916	PHASE2	ACTIVE_NOT_RECRUITING	Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases
NCT04826341	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors
NCT04863885	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	Combination of Ipi/Nivo Plus Sacituzumab Govitecan in Metastatic Cisplatin Ineligible Urothelial Carcinoma Patients
NCT04986579	PHASE2	RECRUITING	Scalp Cooling in MBC
NCT05101096	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors
NCT05119907	PHASE2	ACTIVE_NOT_RECRUITING	Study of Sacituzumab Govitecan in Patients With Solid Tumor
NCT05327530	PHASE2	ACTIVE_NOT_RECRUITING	A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)
NCT05332561	PHASE2	RECRUITING	Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE)
NCT05601440	PHASE2	RECRUITING	Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer
NCT05675579	PHASE2	ACTIVE_NOT_RECRUITING	A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC)
NCT05770531	PHASE2	RECRUITING	Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy
NCT05838521	PHASE2	RECRUITING	A Study of Sacituzumab Govitecan (IMMU-132) in Patients With Recurrent or Persistent Cervical Cancer
NCT05867251	PHASE1/PHASE2	RECRUITING	Study of AVZO-021 in Patients With Advanced Solid Tumors
NCT05884320	PHASE2	RECRUITING	Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers
NCT06028932	PHASE2	ACTIVE_NOT_RECRUITING	A Study of Sacituzumab Govitecan (IMMU-132) in Platinum-resistant Ovarian Cancer Patients
NCT06055465	PHASE2	RECRUITING	Neoadjuvant Sacituzumab Govitecan Plus Pembrolizumab in Resectable Non-Small Cell Lung Cancer
NCT06100874	PHASE2	ACTIVE_NOT_RECRUITING	A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)
NCT06102824	PHASE2	RECRUITING	Organoid-based Functional Precision Therapy for Advanced Breast Cancer
NCT06133517	PHASE2	ACTIVE_NOT_RECRUITING	PeRioperative Immunotherapy Combined With Sacituzumab Govitecan in Muscle Invasive blAdder Cancer
NCT06161532	PHASE2	RECRUITING	Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as High Grade Neuroendocrine Carcinomas, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile C…
NCT06178588	PHASE2	ACTIVE_NOT_RECRUITING	Sacituzumab Govitecan for the Treatment for Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma
NCT06235216	PHASE2	RECRUITING	Sacituzumab govitEcan in THYroid Cancers
NCT06236269	PHASE2	RECRUITING	HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan
NCT06238921	PHASE1/PHASE2	RECRUITING	Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases
NCT06248515	PHASE2	RECRUITING	A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors
NCT06263543	PHASE2	RECRUITING	Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
NCT06311214	PHASE2	RECRUITING	Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial)
NCT06329869	PHASE2	RECRUITING	Sacituzumab Govitecan for Advanced Esophageal Squamous Cell Carcinoma
NCT06409390	PHASE2	RECRUITING	Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer
NCT06462079	PHASE2	NOT_YET_RECRUITING	Sacituzumab Govitecan Combined With Head Radiotherapy for Her2-negative Breast Cancer Brain Metastases
NCT06462092	PHASE1/PHASE2	RECRUITING	Sacituzumab Govitecan and Intrathecal Chemotherapy for Treating Leptomeningeal Metastases From Her2-negative Breast Cancer
NCT06477419	PHASE2	RECRUITING	A Study of Sacituzumab Govitecan in People With Mesothelioma
NCT06528483	PHASE2	NOT_YET_RECRUITING	Bladder Preservation With Sacituzumab Govitecan + Zimberelimab for Muscle-Invasive Bladder Cancer
NCT06612203	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	Clinical Study to Evaluate Debio0123 + Sacituzumab Govitecan Combination in TNBC or HR+/HER2- Advanced Breast Cancer
NCT06665178	PHASE2	RECRUITING	Genomic and Transcriptomic Predictors of Sequential SG Sensitivity After T-DXd in ER+/HER2-Low Metastatic Breast Cancer
NCT06739395	PHASE2	RECRUITING	Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion
NCT06923826	PHASE2	RECRUITING	Sacituzumab Govitecan in Metastatic Salivary Gland and Thyroid Cancers (SG-SGTC)
NCT07011654	PHASE1/PHASE2	RECRUITING	Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)
NCT07063212	PHASE2	RECRUITING	A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)
NCT07151586	PHASE2	NOT_YET_RECRUITING	Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients With Metastatic or Locally Advanced Triple-negative Breast Cancer
NCT07339059	PHASE2	RECRUITING	Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer
NCT07368543	PHASE2	NOT_YET_RECRUITING	Sequencing SG vs. T-DXd in HER2-Low/TROP2-High Metastatic Breast Cancer
NCT07393555	PHASE2	NOT_YET_RECRUITING	Treatment for Advanced Non-small Cell Lung Cancer With Actionable Genomic Alterations After Targeted Treatment and Chemotherapy (An Expanded Lung-MAP Treatment Trial)
NCT07492914	PHASE2	RECRUITING	Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma
NCT07504588	PHASE2	NOT_YET_RECRUITING	Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
NCT03337698	PHASE1/PHASE2	TERMINATED	A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)
NCT03869190	PHASE1/PHASE2	COMPLETED	Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)
NCT03992131	PHASE1/PHASE2	TERMINATED	A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants With a Solid Tumor (SEASTAR)
NCT04143711	PHASE1/PHASE2	COMPLETED	Study of DF1001 in Patients With Advanced Solid Tumors
NCT04927884	PHASE1/PHASE2	TERMINATED	A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies
NCT04958785	PHASE2	TERMINATED	Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer
NCT05008510	PHASE2	WITHDRAWN	P2 Clinical Efficacy & Safety Study of V-111 Monotherapy & Sacituzumab Govitecan-hziy/V-111 Combo Therapy for mTNBC .
NCT05097599	PHASE2	TERMINATED	StrataPATH™ (Precision Indications for Approved Therapies)
NCT05113966	PHASE2	TERMINATED	Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer
NCT05226117	PHASE2	COMPLETED	Sacituzumab Govitecan, Preceding Radical Cystectomy, in Treating Patients With Muscle-invasive Bladder Cancer
NCT05520723	PHASE2	COMPLETED	Preventive stRategy for IMMU132-relatED AEs in TNBC or Luminal Breast Cancer- PRIMED
NCT05581589	PHASE2	TERMINATED	Sacituzumab Govitecan Before Radical Cystectomy for the Treatment of Non-Urothelial Muscle Invasive Bladder Cancer
NCT06123468	PHASE1/PHASE2	COMPLETED	Study Evaluating Treatment of Sacituzumab-govitecan for Patients With Metastatic Esophagogastric Adenocarcinoma
NCT06328387	PHASE1/PHASE2	UNKNOWN	HCQ+ADC vs ADC in the Treatment of Advanced Breast Cancer
NCT06865677	PHASE2	TERMINATED	Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas
NCT07328490	PHASE1/PHASE2	WITHDRAWN	Bispecific T-Cell Engager Tarlatamab and TROP2 Targeted Antibody Drug Conjugate Sacituzumab Govitecan in Previously Treated Extensive-Stage Small Cell Lung Cancer and Extrapulmonary Neuroendocrine Cancer
NCT04617522	PHASE1	RECRUITING	Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
NCT04794699	PHASE1	ACTIVE_NOT_RECRUITING	Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
NCT05006794	PHASE1	ACTIVE_NOT_RECRUITING	Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies
NCT05143229	PHASE1	ACTIVE_NOT_RECRUITING	Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer
NCT05833867	PHASE1	RECRUITING	Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer
NCT06167317	PHASE1	RECRUITING	Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors
NCT07163481	PHASE1	NOT_YET_RECRUITING	A Trial to Evaluate Sacituzumab Govitecan in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Metastatic Breast Cancer Progressed on CDK4/6 Inhibitors

Clinical evidence (CIViC)

Variant × indication × effect (3 predictive associations from 3 curated evidence items):

Variant	Indication	Effect	Therapy	Level	CIViC
TACSTD2 T256R	Triple-receptor Negative Breast Cancer	Resistance	Sacituzumab Govitecan	CIViC B	EID12265
TOP1 E418K AND TOP1 -122fs	Triple-receptor Negative Breast Cancer	Resistance	Sacituzumab Govitecan	CIViC C	EID12266
MMP1 Overexpression	Estrogen-receptor Positive Breast Cancer	Resistance	Sacituzumab Govitecan	CIViC D	EID12597

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).