LAST UPDATED
April 28, 2026
Clinicaltrials.gov ID
EudraCT ID
CTSID
OVERVIEW
A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors (TROPiCS-03)
PROTOCOL SUMMARY
The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy, in participants with metastatic (cancer that has spread) solid tumors.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Metastatic Solid Tumor
Gender
N/A
Date
October 2019 - January 2025
Study Type
Interventional
Study Phase
Phase 2
Product
Sacituzumab Govitecan-hziy
Eligibility information
Inclusion criteria
- Individuals with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors
- 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 had a prior anti-cancer biologic agent within 4 weeks prior to study Day 1 or have had prior chemotherapy, targeted small molecule therapy, radiation therapy within 2 weeks prior to Study Day 1
- 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
- Additional cohort specific exclusion criteria
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (65)
Alaska Oncology & Hematology, LLC
Anchorage, Alaska, United States, 99508
USOR - Arizona Oncology - Glendale - Saguaro Cancer Center
Glendale, Arizona, United States, 85308
Arizona Oncology Associates PC-HAL
Goodyear, Arizona, United States, 85395
UCLA Hematology/Oncology
Los Angeles, California, United States, 90095
TRIO-US Central Administration
Whittier, California, United States, 90602
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Smilow Cancer Hospital at Yale
New Haven, Connecticut, United States, 06520
SIU School of Medicine, Simmons Cancer Institute at SIU
Springfield, Illinois, United States, 62702
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Christus Highland Cancer Treatment Center
Shreveport, Louisiana, United States, 71105
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
North Mississippi Medical Center - Hematology and Oncology - Tupelo
Tupelo, Mississippi, United States, 38801
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States, 63110
Comprehensive Cancer of Nevada
Las Vegas, Nevada, United States, 89052
New York Oncology Hematology - Albany Medical Center
Albany, New York, United States, 12208
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Weill Cornell Medicine - Upper East Side
New York, New York, United States, 10065
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Willamette Valley Cancer Institute and Research Center - Eugene
Eugene, Oregon, United States, 97401
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Blue Ridge Cancer Care - Wytheville
Blacksburg, Virginia, United States, 24060
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
Southern Highlands Cancer Center
Bowral, New South Wales, Australia, 2576
Calvary Mater Newcastle Hospital
Waratah, New South Wales, Australia, 2298
Mater Cancer Centre, Mater Misericordiae Limited
South Brisbane, Queensland, Australia, 4101
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia, 5112
Monash Medical Centre, Monash Health
Clayton, Victoria, Australia, 3168
The Andrew Love Cancer Centre, Geelong Hospital
Geelong, Victoria, Australia, 3220
London Health Sciences Centre- Victoria Hospital
London, Canada, N6A 5W9
Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital
Shatin, Hong Kong,
Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
Taoyuan City, Taiwan, 33305
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