Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors

Metastatic Solid Tumor Clinical Trial

— TROPiCS-03  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03964727
• Other study ID #: IMMU-132-11
• Secondary ID: 2019-000579-18
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 15, 2019
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 165
• Est. completion date: June 2026
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Solid Tumor
• Neoplasms

Intervention

Drug:
• Sacituzumab Govitecan-hziy
Administered intravenously

Locations

Country	Name	City	State
Australia	Pindara Private Hospital	Benowa	Queensland
Australia	Southern Highlands Cancer Center	Bowral	New South Wales
Australia	Monash Medical Centre, Monash Health	Clayton	Victoria
Australia	Lyell McEwin Hospital	Elizabeth Vale	South Australia
Australia	The Andrew Love Cancer Centre, Geelong Hospital	Geelong	Victoria
Australia	Macquarie University	North Ryde	New South Wales
Australia	Mater Cancer Centre, Mater Misericordiae Limited	South Brisbane	Queensland
Australia	Calvary Mater Newcastle Hospital	Waratah	New South Wales
Australia	Blacktown Hospital	Westmead	New South Wales
Belgium	Cliniques Universitaires UCL Saint-Luc	Brussels
Belgium	Grand Hopital de Charleroi asbl (GHdC)	Charleroi
Canada	Cross Cancer Institute	Edmonton
Canada	London Health Sciences Centre- Victoria Hospital	London
Canada	Jewish General Hospital	Montreal
Canada	The Ottawa Hospital	Ottawa
France	Institut Bergonie	Bordeaux
France	Centre George Francois Leclerc	Dijon
France	Institut Claudius Régaud - IUCT Oncopole	Toulouse
France	Institut Gustave Roussy	Villejuif
Hong Kong	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
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Institut Català d'Oncologia	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Clínico Universitario de Valencia	Valencia
Taiwan	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	Tainan City
Taiwan	Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital	Taoyuan City
United States	New York Oncology Hematology - Albany Medical Center	Albany	New York
United States	Alaska Oncology & Hematology, LLC	Anchorage	Alaska
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan
United States	University of Colorado Hospital - Anschutz Cancer Pavilion	Aurora	Colorado
United States	Blue Ridge Cancer Care - Wytheville	Blacksburg	Virginia
United States	Montefiore Medical Center	Bronx	New York
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Willamette Valley Cancer Institute and Research Center - Eugene	Eugene	Oregon
United States	Providence Regional Cancer Partnership	Everett	Washington
United States	Virginia Cancer Specialists, PC	Fairfax	Virginia
United States	Parkview Research Center	Fort Wayne	Indiana
United States	PathGroup Labs, LLC	Fort Wayne	Indiana
United States	USOR - Arizona Oncology - Glendale - Saguaro Cancer Center	Glendale	Arizona
United States	Arizona Oncology Associates PC-HAL	Goodyear	Arizona
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Comprehensive Cancer of Nevada	Las Vegas	Nevada
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	UCLA Hematology/Oncology	Los Angeles	California
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Smilow Cancer Hospital at Yale	New Haven	Connecticut
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	David C. Pratt Center	Saint Louis	Missouri
United States	Washington University School of Medicine - Siteman Cancer Center	Saint Louis	Missouri
United States	Christus Highland Cancer Treatment Center	Shreveport	Louisiana
United States	Highlands Oncology Group	Springdale	Arkansas
United States	SIU School of Medicine, Simmons Cancer Institute at SIU	Springfield	Illinois
United States	North Mississippi Medical Center - Hematology and Oncology - Tupelo	Tupelo	Mississippi
United States	Texas Oncology - Tyler	Tyler	Texas
United States	TRIO-US Central Administration	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Hong Kong,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment	ORR, is defined as the proportion of participants who achieve the best overall response, confirmed complete response (CR) or partial response (PR). Responses are based on the investigator-assessed tumor response using RECIST 1.1 criteria.	Up to 3 years
Secondary	Objective Response Rate (ORR) According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment	ORR, is defined as the proportion of participants who achieve the best overall response, confirmed CR or PR. Responses are based on BICR assessment using RECIST 1.1 criteria.	Up to 3 years
Secondary	Duration of Response (DOR) According to RECIST 1.1 by BICR	DOR, is calculated as the date of the first evaluation showing documented response, either PR or CR, to the date of the first progression of disease (PD) or death from any cause, whichever comes first. Response are according to RECIST 1.1 by BICR	Up to 3 years
Secondary	Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR	CBR is defined as the proportion of participants who achieve the best overall response, CR + PR + stable disease (SD). Responses are according to RECIST 1.1 by BICR.	Up to 3 years
Secondary	Progression-free Survival (PFS) According to RECIST 1.1 by BICR	PFS, is defined as the time from first dose until objective tumor progression or death from any cause, whichever comes first. Responses are according to RECIST 1.1 by BICR	Up to 3 years
Secondary	DOR According to RECIST 1.1 by Investigator's Assessment	DOR, is calculated as the date of the first evaluation showing documented response, either PR or CR, to the date of the first PD or death from any cause, whichever comes first. Responses are based on the investigator-assessed tumor response using RECIST 1.1 criteria.	Up to 3 years
Secondary	Clinical Benefit Rate (CBR) According to RECIST 1.1 by Investigator's Assessment	CBR, is defined as the proportion of participants who achieve the best overall response, CR + PR + SD. Responses are based on the investigator-assessed tumor response using RECIST 1.1 criteria.	Up to 3 years
Secondary	Progression-free Survival (PFS) According to RECIST 1.1 by Investigator's Assessment	PFS, is defined as the time from first dose until objective tumor progression or death from any cause, whichever comes first. Responses are based on the investigator-assessed tumor response using RECIST 1.1 criteria.	Up to 3 years
Secondary	Overall Survival (OS)	Overall survival is defined as the interval from the first dose date of drug to death from any cause.	Up to 3 years
Secondary	Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)		Up to 3 years
Secondary	Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities		Up to 3 years
Secondary	Pharmacokinetic (PK) Parameter: Serum Concentration of Sacituzumab Govitecan-hziy		First dose date up to last dose date plus 30 days (up to 3 years)
Secondary	Immunogenicity Assessment	Number of participants who test positive for anti-drug antibodies to sacituzumab govitecan-hziy will be reported.	First dose date up to last dose date plus 30 days (up to 3 years)

External Links

•   Gilead Clinical Trials Website