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ACTIVE NOT RECRUITING

NCT03964727

PHASE2

Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

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.

Official title: A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

223

Start Date

2019-10-15

Completion Date

2026-12

Last Updated

2026-01-30

Healthy Volunteers

Conditions

Metastatic Solid Tumor

Interventions

DRUG

Sacituzumab Govitecan-hziy

Administered intravenously

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.

Locations (65)

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

Clinical Research Directory

Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (65)