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Clinical Trials in Canada / NCT03964727
Active, not recruiting Phase 2

Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors

NCT03964727 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2019-10-15
Last updated
2026-04-28

Condition(s) studied

Metastatic Solid Tumor

Investigational drug(s) / intervention(s)

Sacituzumab Govitecan-hziy →

Sacituzumab Govitecan-hziy: Administered intravenously

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key 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 Key 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.

Primary outcome measure(s)

Trial sites (65)

FacilityCityRegionStatus
Alaska Oncology & Hematology, LLC Anchorage Alaska
USOR - Arizona Oncology - Glendale - Saguaro Cancer Center Glendale Arizona
Arizona Oncology Associates PC-HAL Goodyear Arizona
Highlands Oncology Group Springdale Arkansas
UCLA Hematology/Oncology Los Angeles California
TRIO-US Central Administration Whittier California
University of Colorado Hospital - Anschutz Cancer Pavilion Aurora Colorado
Smilow Cancer Hospital at Yale New Haven Connecticut
SIU School of Medicine, Simmons Cancer Institute at SIU Springfield Illinois
PathGroup Labs, LLC Fort Wayne Indiana
Parkview Research Center Fort Wayne Indiana
University of Kentucky Medical Center Lexington Kentucky
Christus Highland Cancer Treatment Center Shreveport Louisiana
University of Michigan Rogel Cancer Center Ann Arbor Michigan
Karmanos Cancer Institute Detroit Michigan
North Mississippi Medical Center - Hematology and Oncology - Tupelo Tupelo Mississippi
Washington University School of Medicine - Siteman Cancer Center St Louis Missouri
David C. Pratt Center St Louis Missouri
Comprehensive Cancer of Nevada Las Vegas Nevada
New York Oncology Hematology - Albany Medical Center Albany New York
Memorial Sloan Kettering Cancer Center New York New York
Weill Cornell Medicine - Upper East Side New York New York
Montefiore Medical Center The Bronx New York
University Hospitals Cleveland Medical Center Cleveland Ohio
Willamette Valley Cancer Institute and Research Center - Eugene Eugene Oregon
Tennessee Oncology, PLLC Nashville Tennessee
The University of Texas MD Anderson Cancer Center Houston Texas
Texas Oncology - Tyler Tyler Texas
Blue Ridge Cancer Care - Wytheville Blacksburg Virginia
Virginia Cancer Specialists, PC Fairfax Virginia
Providence Regional Cancer Partnership Everett Washington
Southern Highlands Cancer Center Bowral New South Wales
Macquarie University North Ryde New South Wales
Calvary Mater Newcastle Hospital Waratah New South Wales
Blacktown Hospital Westmead New South Wales
Pindara Private Hospital Benowa Queensland
Mater Cancer Centre, Mater Misericordiae Limited South Brisbane Queensland
Lyell McEwin Hospital Elizabeth Vale South Australia
Monash Medical Centre, Monash Health Clayton Victoria
The Andrew Love Cancer Centre, Geelong Hospital Geelong Victoria

+ 25 more sites — see the full list on the official registry below.

More Gilead Sciences trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03964727 on ClinicalTrials.gov ↗ ← All trials in Canada