Study Details

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

Medical Condition

Metastatic Solid Tumor

Gender

N/A

Date

October 2019 - June 2024

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 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 (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

Highlands Oncology Group

Springdale, Arkansas, United States, 72762

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

PathGroup Labs, LLC

Fort Wayne, Indiana, United States, 46804

Parkview Research Center

Fort Wayne, Indiana, United States, 46845

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

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

North Mississippi Medical Center - Hematology and Oncology - Tupelo

Tupelo, Mississippi, United States, 38801

Washington University School of Medicine - Siteman Cancer Center

Saint Louis, Missouri, United States, 63110

David C. Pratt Center

Saint Louis, Missouri, United States, 63141

Comprehensive Cancer of Nevada

Las Vegas, Nevada, United States, 89052

New York Oncology Hematology - Albany Medical Center

Albany, New York, United States, 12208

Montefiore Medical Center

Bronx, New York, United States, 10467

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

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37203

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Texas Oncology - Tyler

Tyler, Texas, United States, 75702

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

Macquarie University

North Ryde, New South Wales, Australia, 2109

Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia, 2298

Blacktown Hospital

Westmead, New South Wales, Australia, 2145

Pindara Private Hospital

Benowa, Queensland, Australia, 4217

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

Cliniques Universitaires UCL Saint-Luc

Brussels, Belgium, 1200

Grand Hopital de Charleroi asbl (GHdC)

Charleroi, Belgium, 6000

Cross Cancer Institute

Edmonton, Canada, T6G 1Z2

London Health Sciences Centre- Victoria Hospital

London, Canada, N6A 5W9

Jewish General Hospital

Montreal, Canada, H3T 1E2

The Ottawa Hospital

Ottawa, Canada, K1H 8L6

Institut Bergonie

Bordeaux, France, 33000

Centre George Francois Leclerc

Dijon, France, 21000

Institut Claudius Régaud - IUCT Oncopole

Toulouse, France, 31059

Institut Gustave Roussy

Villejuif, France, 94805

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, 08041

Institut Català d'Oncologia

Barcelona, Spain, 08908

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 8035

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Changhua Christian Hospital

Changhua City, Taiwan

Taipei TzuChi Hospital

New Taipei City, Taiwan

Chi Mei Medical Center

Tainan City, Taiwan

National Cheng Kung University Hospital