Product Description
Sacituzumab govitecan-hziy is a type of targeted therapy drug called an antibody-drug conjugate. It consists of a monoclonal antibody linked to a toxic drug called SN-38 that binds to a protein on the surface of some cancer cells. The linked drug enters these cancer cells and blocks an enzyme called topoisomerase I. This damages the DNA of the cancer cells and kills them. (Sourced from: https://www.cancer.gov/about-cancer/treatment/drugs/sacituzumabgovitecan-hziy)
Mechanisms of Action: TROP2 Inhibitor
Novel Mechanism: No
Modality: Antibody Drug Conjugate
Route of Administration: Intravenous
FDA Designation: Accelerated Approval - Breast Cancer|Oncology Solid Tumor Unspecified|Triple Negative Breast CancerAccelerated Approval - Oncology Solid Tumor Unspecified|Transitional Cell CarcinomaBreakthrough Therapy - Small Cell Lung CancerFast Track - Oncology Solid Tumor Unspecified|Transitional Cell CarcinomaOrphan Drug - Breast Cancer|Oncology Solid Tumor Unspecified|Triple Negative Breast CancerOrphan Drug - Glioblastoma *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Brazil | Canada | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Poland | Portugal | Romania | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Gilead Sciences
Company Location: Western America
Company CEO: Daniel P. O’Day
Additional Commercial Interests: Everest Medicines
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 97
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Gilead Sciences presented P3 Breast Cancer results on 2025-11-07 for Sacituzumab govitecan
- Clinical Outcomes Reported - Gilead Sciences presented P3 Triple Negative Breast Cancer results on 2025-10-19 for Sacituzumab govitecan
- Clinical Outcomes Reported - Gilead Sciences presented P3 Triple Negative Breast Cancer results on 2025-05-23 for Sacituzumab govitecan
Highest Development Phases
Phase 3: Breast Cancer|Endometrial Cancer|Non-Small-Cell Lung Cancer|Small Cell Lung Cancer|Transitional Cell Carcinoma|Triple Negative Breast Cancer
Phase 2: Adenocarcinoma|Alopecia|Anaplastic Thyroid Carcinoma|Bladder Cancer|Brain Cancer|Cervical Cancer|Esophageal Cancer|Gastrointestinal Cancer|Head and Neck Cancer|Laryngeal Cancer|Male Breast Cancer|Mesothelioma|Mouth Cancer|Muscle Cancer|Oncology Solid Tumor Unspecified|Oropharyngeal Cancer|Ovarian Cancer|Prostate Cancer|Renal Cell Carcinoma|Salivary Gland Cancer|Salivary Gland Diseases|Squamous Cell Carcinoma|Thymoma|Thyroid Cancer|Uterine Cancer
Phase 1: Biliary Tract Cancer|Colorectal Cancer|Liver Failure|Pancreatic Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06065371 |
HFH-23-03 | P1 |
Recruiting |
Colorectal Cancer|Gastrointestinal Cancer|Esophageal Cancer|Biliary Tract Cancer|Pancreatic Cancer |
2026-12-01 |
50% |
2025-12-20 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT04617522 |
IMMU-132-15 | P1 |
Recruiting |
Liver Failure |
2026-12-01 |
50% |
2024-07-27 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05833867 |
RAD-SG | P1 |
Recruiting |
Transitional Cell Carcinoma|Bladder Cancer |
2025-12-01 |
50% |
2025-01-03 |
Primary Completion Date|Primary Endpoints|Start Date|Treatments |
NCT06923826 |
TROP2 | P2 |
Recruiting |
Thyroid Cancer|Salivary Gland Diseases|Salivary Gland Cancer |
2030-04-01 |
12% |
2025-07-26 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT06477419 |
NCT06477419 | P2 |
Recruiting |
Mesothelioma |
2029-06-21 |
12% |
2024-06-28 |
Primary Endpoints|Treatments |
NCT05884320 |
NCI-2023-04260 | P2 |
Recruiting |
Salivary Gland Cancer |
2028-07-31 |
12% |
2026-01-10 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT07063212 |
NCT07063212 | P2 |
Recruiting |
Squamous Cell Carcinoma|Oropharyngeal Cancer|Head and Neck Cancer|Laryngeal Cancer|Mouth Cancer |
2028-01-02 |
12% |
2025-07-15 |
Primary Endpoints|Treatments |
NCT06235216 |
SETHY | P2 |
Recruiting |
Thyroid Cancer|Anaplastic Thyroid Carcinoma |
2027-12-01 |
64% |
2024-09-26 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT04724018 |
NCT04724018 | P2 |
Recruiting |
Bladder Cancer|Renal Cell Carcinoma|Transitional Cell Carcinoma |
2027-02-01 |
12% |
2025-11-05 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06682728 |
UCI 23-59 | P2 |
Recruiting |
Bladder Cancer|Muscle Cancer|Transitional Cell Carcinoma |
2026-12-01 |
12% |
2024-11-22 |
Primary Endpoints|Treatments|Trial Status |
NCT06100874 |
SATEEN | P2 |
Recruiting |
Male Breast Cancer |
2026-11-30 |
12% |
2024-03-16 |
Primary Endpoints|Start Date|Treatments |
NCT06329869 |
SG-ESCC | P2 |
Recruiting |
Esophageal Cancer|Squamous Cell Carcinoma |
2026-11-01 |
12% |
2024-12-03 |
Primary Endpoints|Start Date|Trial Status |
NCT06401824 |
CO-NL-979-6888 | P2 |
Recruiting |
Brain Cancer|Non-Small-Cell Lung Cancer|Small Cell Lung Cancer |
2026-11-01 |
12% |
2025-05-07 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT06028932 |
NCT06028932 | P2 |
Active, not recruiting |
Ovarian Cancer |
2026-11-01 |
2% |
2025-09-16 |
|
NCT05119907 |
EVER-132-003 | P2 |
Active, not recruiting |
Oncology Solid Tumor Unspecified |
2026-10-01 |
12% |
2025-11-18 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT04986579 |
NCT04986579 | P2 |
Recruiting |
Alopecia|Breast Cancer |
2026-06-01 |
75% |
2024-06-28 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05838521 |
NCT05838521 | P2 |
Recruiting |
Uterine Cancer|Cervical Cancer |
2026-06-01 |
12% |
2024-01-12 |
Primary Endpoints|Start Date |
NCT06248515 |
STUDY00007501 | P2 |
Recruiting |
Thymoma |
2026-04-01 |
12% |
2024-05-30 |
Primary Completion Date|Primary Endpoints|Start Date |
NCT04468061 |
Saci-IO TNBC | P2 |
Recruiting |
Triple Negative Breast Cancer |
2026-04-01 |
12% |
2024-04-17 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05186974 |
EVOKE-02 | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2026-02-01 |
2% |
2024-08-24 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT06123468 |
SAGA | P2 |
Completed |
Gastrointestinal Cancer|Adenocarcinoma|Esophageal Cancer |
2026-01-07 |
66% |
2026-01-09 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT04251416 |
NCT04251416 | P2 |
Active, not recruiting |
Endometrial Cancer |
2025-12-01 |
12% |
2025-08-14 |
Primary Endpoints|Treatments|Trial Status |
NCT03725761 |
UW18043 | P2 |
Active, not recruiting |
Prostate Cancer |
2024-04-18 |
12% |
2025-04-26 |
|
NCT04639986 |
EVER-132-002 | P3 |
Active, not recruiting |
Breast Cancer |
2025-12-01 |
79% |
2024-06-28 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2024-512279-10-00 |
GS-US-595-6184 | P3 |
Recruiting |
Triple Negative Breast Cancer |
2033-05-20 |
2025-05-02 |
Treatments |
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