Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors
NCT ID: NCT03964727
Last Updated: 2026-01-30
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
223 participants
INTERVENTIONAL
2019-10-15
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 4: Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
Participants with ES-SCLC will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.
Sacituzumab Govitecan-hziy
Administered intravenously
Cohort 1 Group 1: NSCLC [Adenocarcinoma + Squamous Cell Carcinoma (SCC)]
Based on protocol amendment 1, participants with non-small cell lung cancer (NSCLC) subtypes such as adenocarcinoma and SCC with high trophoblast cell-surface antigen 2 (Trop-2) expression will receive sacituzumab govitecan-hziy (SG) 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.
Sacituzumab Govitecan-hziy
Administered intravenously
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.
Sacituzumab Govitecan-hziy
Administered intravenously
Cohort 1 Group 3: NSCLC (SCC)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.
Sacituzumab Govitecan-hziy
Administered intravenously
Cohort 2: Head And Neck Squamous Cell Carcinoma (HNSCC)
Participants with HNSCC will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.
Sacituzumab Govitecan-hziy
Administered intravenously
Cohort 3: Endometrial Cancer (EC)
Participants with EC will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.
Sacituzumab Govitecan-hziy
Administered intravenously
Interventions
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Sacituzumab Govitecan-hziy
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* NSCLC \[adenocarcinoma or squamous cell carcinoma (SCC)\] that has progressed after prior platinum-based chemotherapy and programmed death-(ligand) 1 (PD-(L)1) directed therapy
* HNSCC that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed
* Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed.
* Extensive stage SCLC that has progressed after prior platinum-based chemotherapy and PD-(L)1 directed therapy. No more than one prior line of systemic treatment is allowed (re-challenge with the same initial regimen is not allowed)
* Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1
* Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation
* Adequate hepatic and renal function \[Creatinine Clearance (CrCl) ≥30mL/min\]
* Individual must have at least a 3-month life expectancy
* Have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Exclusion Criteria
* Have not recovered (i.e., ≤ Grade 1) from adverse events due to a previously administered agent
* Have previously received topoisomerase I inhibitors
* Have an active second malignancy
* Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Individuals with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases and are taking ≤20 mg/day of prednisone or its equivalent. All individuals with carcinomatous meningitis are excluded regardless of clinical stability
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Alaska Oncology & Hematology, LLC
Anchorage, Alaska, United States
USOR - Arizona Oncology - Glendale - Saguaro Cancer Center
Glendale, Arizona, United States
Arizona Oncology Associates PC-HAL
Goodyear, Arizona, United States
Highlands Oncology Group
Springdale, Arkansas, United States
UCLA Hematology/Oncology
Los Angeles, California, United States
TRIO-US Central Administration
Whittier, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States
Smilow Cancer Hospital at Yale
New Haven, Connecticut, United States
SIU School of Medicine, Simmons Cancer Institute at SIU
Springfield, Illinois, United States
PathGroup Labs, LLC
Fort Wayne, Indiana, United States
Parkview Research Center
Fort Wayne, Indiana, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Christus Highland Cancer Treatment Center
Shreveport, Louisiana, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
North Mississippi Medical Center - Hematology and Oncology - Tupelo
Tupelo, Mississippi, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
David C. Pratt Center
St Louis, Missouri, United States
Comprehensive Cancer of Nevada
Las Vegas, Nevada, United States
New York Oncology Hematology - Albany Medical Center
Albany, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medicine - Upper East Side
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Willamette Valley Cancer Institute and Research Center - Eugene
Eugene, Oregon, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Blue Ridge Cancer Care - Wytheville
Blacksburg, Virginia, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Southern Highlands Cancer Center
Bowral, New South Wales, Australia
Macquarie University
North Ryde, New South Wales, Australia
Calvary Mater Newcastle Hospital
Waratah, New South Wales, Australia
Blacktown Hospital
Westmead, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
Mater Cancer Centre, Mater Misericordiae Limited
South Brisbane, Queensland, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Monash Medical Centre, Monash Health
Clayton, Victoria, Australia
The Andrew Love Cancer Centre, Geelong Hospital
Geelong, Victoria, Australia
Cliniques Universitaires UCL Saint-Luc
Brussels, , Belgium
Grand Hopital de Charleroi asbl (GHdC)
Charleroi, , Belgium
Cross Cancer Institute
Edmonton, , Canada
London Health Sciences Centre- Victoria Hospital
London, , Canada
Jewish General Hospital
Montreal, , Canada
The Ottawa Hospital
Ottawa, , Canada
Institut Bergonie
Bordeaux, , France
Centre George Francois Leclerc
Dijon, , France
Institut Claudius Régaud - IUCT Oncopole
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Hong Kong Integrated Oncology Centre
Central, , Hong Kong
Hong Kong Sanatorium & Hospital
Happy Valley, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
Hong Kong United Oncology Center
Kowloon, , Hong Kong
Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital
Shatin, , Hong Kong
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Institut Català d'Oncologia
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Changhua Christian Hospital
Changhua, , Taiwan
Taipei TzuChi Hospital
New Taipei City, , Taiwan
Chi Mei Medical Center
Tainan, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
Taoyuan, , Taiwan
Countries
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References
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Santin AD, Corr BR, Spira A, Willmott L, Butrynski J, Tse KY, Patel J, Mekan S, Wu T, Lin KW, Kuo P, Dumbrava EE. Efficacy and Safety of Sacituzumab Govitecan in Patients With Advanced Solid Tumors (TROPiCS-03): Analysis in Patients With Advanced Endometrial Cancer. J Clin Oncol. 2024 Oct 10;42(29):3421-3429. doi: 10.1200/JCO.23.02767. Epub 2024 Jul 31.
Michel L, Jimeno A, Sukari A, Beck JT, Chiu J, Ahern E, Hilton J, Even C, Zanetta S, Mekan S, Patel J, Wu T, Dumbrava EE. Sacituzumab Govitecan in Patients with Relapsed/Refractory Advanced Head and Neck Squamous Cell Carcinoma: Results from the Phase II TROPiCS-03 Basket Study. Clin Cancer Res. 2025 Mar 3;31(5):832-838. doi: 10.1158/1078-0432.CCR-24-2523.
Dowlati A, Chiang AC, Cervantes A, Babu S, Hamilton E, Wong SF, Tazbirkova A, Sullivan IG, van Marcke C, Italiano A, Patel J, Mekan S, Wu T, Waqar SN. Phase 2 Open-Label Study of Sacituzumab Govitecan as Second-Line Therapy in Patients With Extensive-Stage SCLC: Results From TROPiCS-03. J Thorac Oncol. 2025 Jun;20(6):799-808. doi: 10.1016/j.jtho.2024.12.028. Epub 2025 Jan 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2019-000579-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-513611-28
Identifier Type: OTHER
Identifier Source: secondary_id
IMMU-132-11
Identifier Type: -
Identifier Source: org_study_id
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