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)
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment — Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years ORR was defined as the percentage of participants who had the best overall response of either complete response (CR) or partial response (PR). Responses are based on the investigator-assessed tumor response using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria for each histologic cohort. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: \>30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. The ORR rate was calculated with a two-sided exact 95% CI using the Clopper-Pearson method. Percentages are rounded off.
Trial sites (65)
Facility
City
Region
Status
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.
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.