Clinical trial NCT03964727: Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors
Official title: A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Metastatic Solid Tumor
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2019-05-28
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: Key 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

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 outcomes:
measure: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment
timeFrame: Up to 3 years
Secondary outcomes:
measure: Objective Response Rate (ORR) According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment
timeFrame: Up to 3 years
measure: Duration of Response (DOR) According to RECIST 1.1 by BICR
timeFrame: Up to 3 years
measure: Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR
timeFrame: Up to 3 years
measure: Progression-free Survival (PFS) According to RECIST 1.1 by BICR
timeFrame: Up to 3 years
measure: DOR According to RECIST 1.1 by Investigator's Assessment
timeFrame: Up to 3 years
measure: Clinical Benefit Rate (CBR) According to RECIST 1.1 by Investigator's Assessment
timeFrame: Up to 3 years
measure: Progression-free Survival (PFS) According to RECIST 1.1 by Investigator's Assessment
timeFrame: Up to 3 years
measure: Overall Survival (OS)
timeFrame: Up to 3 years
measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
timeFrame: Up to 3 years
measure: Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
timeFrame: Up to 3 years
measure: Pharmacokinetic (PK) Parameter: Serum Concentration of Sacituzumab Govitecan-hziy
timeFrame: First dose date up to last dose date plus 30 days (up to 3 years)
measure: Immunogenicity Assessment
timeFrame: First dose date up to last dose date plus 30 days (up to 3 years)
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Oncology & Hematology, LLC
state: Alaska
city: Glendale
country: United States
facility: USOR - Arizona Oncology - Glendale - Saguaro Cancer Center
state: Arizona
city: Goodyear
country: United States
facility: Arizona Oncology Associates PC-HAL
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology
state: California
city: Whittier
country: United States
facility: TRIO-US Central Administration
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital - Anschutz Cancer Pavilion
state: Colorado
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale
state: Connecticut
city: Springfield
country: United States
facility: SIU School of Medicine, Simmons Cancer Institute at SIU
state: Illinois
city: Fort Wayne
country: United States
facility: PathGroup Labs, LLC
state: Indiana
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Shreveport
country: United States
facility: Christus Highland Cancer Treatment Center
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Tupelo
country: United States
facility: North Mississippi Medical Center - Hematology and Oncology - Tupelo
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University School of Medicine - Siteman Cancer Center
state: Missouri
city: Saint Louis
country: United States
facility: David C. Pratt Center
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer of Nevada
state: Nevada
city: Albany
country: United States
facility: New York Oncology Hematology - Albany Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine - Upper East Side
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center - Eugene
state: Oregon
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Blacksburg
country: United States
facility: Blue Ridge Cancer Care - Wytheville
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
city: Bowral
country: Australia
facility: Southern Highlands Cancer Center
state: New South Wales
city: North Ryde
country: Australia
facility: Macquarie University
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Blacktown Hospital
state: New South Wales
city: Benowa
country: Australia
facility: Pindara Private Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Cancer Centre, Mater Misericordiae Limited
state: Queensland
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre, Monash Health
state: Victoria
city: Geelong
country: Australia
facility: The Andrew Love Cancer Centre, Geelong Hospital
state: Victoria
city: Brussels
country: Belgium
facility: Cliniques Universitaires UCL Saint-Luc
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi asbl (GHdC)
city: Edmonton
country: Canada
facility: Cross Cancer Institute
city: London
country: Canada
facility: London Health Sciences Centre- Victoria Hospital
city: Montreal
country: Canada
facility: Jewish General Hospital
city: Ottawa
country: Canada
facility: The Ottawa Hospital
city: Bordeaux
country: France
facility: Institut Bergonie
city: Dijon
country: France
facility: Centre George Francois Leclerc
city: Toulouse
country: France
facility: Institut Claudius Régaud - IUCT Oncopole
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Central
country: Hong Kong
facility: Hong Kong Integrated Oncology Centre
city: Happy Valley
country: Hong Kong
facility: Hong Kong Sanatorium & Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Kowloon
country: Hong Kong
facility: Hong Kong United Oncology Center
city: Shatin
country: Hong Kong
facility: Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Institut Català d'Oncologia
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
city: New Taipei City
country: Taiwan
facility: Taipei TzuChi Hospital
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: