Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors (TROPiCS-03)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Solid Tumor
• Intervention / Treatment: Drug: Sacituzumab Govitecan-hziy

• Study Type: Interventional
• Enrollment (Estimated): 165
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Gilead Clinical Study Information Center; Phone Number: 1-833-445-3230 (GILEAD-0); Email: GileadClinicalTrials@gilead.com

Study Locations

• Australia
  • New South Wales
    • Bowral, New South Wales, Australia, 2576
      • Southern Highlands Cancer Center
    • North Ryde, New South Wales, Australia, 2109
      • Macquarie University
    • Waratah, New South Wales, Australia, 2298
      • Calvary Mater Newcastle Hospital
    • Westmead, New South Wales, Australia, 2145
      • Blacktown Hospital
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • Pindara Private Hospital
    • South Brisbane, Queensland, Australia, 4101
      • Mater Cancer Centre, Mater Misericordiae Limited
  • South Australia
    • Elizabeth Vale, South Australia, Australia, 5112
      • Lyell McEwin Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre, Monash Health
    • Geelong, Victoria, Australia, 3220
      • The Andrew Love Cancer Centre, Geelong Hospital
• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Ucl Saint-Luc
  • Charleroi, Belgium, 6000
    • Grand Hopital de Charleroi asbl (GHdC)
• Canada
  • Edmonton, Canada, T6G 1Z2
    • Cross Cancer Institute
  • London, Canada, N6A 5W9
    • London Health Sciences Centre- Victoria Hospital
  • Montreal, Canada, H3T 1E2
    • Jewish General Hospital
  • Ottawa, Canada, K1H 8L6
    • The Ottawa Hospital
• France
  • Bordeaux, France, 33000
    • Institut Bergonié
  • Dijon, France, 21000
    • Centre George François Leclerc
  • Toulouse, France, 31059
    • Institut Claudius Régaud - IUCT Oncopole
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Hong Kong
  • Central, Hong Kong
    • Hong Kong Integrated Oncology Centre
  • Happy Valley, Hong Kong
    • Hong Kong Sanatorium & Hospital
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Kowloon, Hong Kong
    • Hong Kong United Oncology Center
  • Shatin, Hong Kong
    • Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital
• Spain
  • Barcelona, Spain, 8035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08908
    • Institut Catala d'Oncologia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
• Taiwan
  • Changhua City, Taiwan
    • Changhua Christian Hospital
  • New Taipei City, Taiwan
    • Taipei TzuChi Hospital
  • Tainan City, Taiwan
    • National Cheng Kung University Hospital
  • Tainan City, Taiwan
    • Chi Mei Medical Center
  • Taoyuan City, Taiwan, 33305
    • Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Oncology & Hematology, LLC
  • Arizona
    • Glendale, Arizona, United States, 85308
      • USOR - Arizona Oncology - Glendale - Saguaro Cancer Center
    • Goodyear, Arizona, United States, 85395
      • Arizona Oncology Associates PC-HAL
  • Arkansas
    • Springdale, Arkansas, United States, 72762
      • Highlands Oncology Group
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Hematology/Oncology
    • Whittier, California, United States, 90602
      • TRIO-US Central Administration
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital - Anschutz Cancer Pavilion
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Smilow Cancer Hospital at Yale
  • Illinois
    • Springfield, Illinois, United States, 62702
      • SIU School of Medicine, Simmons Cancer Institute at SIU
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Research Center
    • Fort Wayne, Indiana, United States, 46804
      • PathGroup Labs, LLC
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Medical Center
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Christus Highland Cancer Treatment Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Rogel Cancer Center
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center - Hematology and Oncology - Tupelo
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine - Siteman Cancer Center
    • Saint Louis, Missouri, United States, 63141
      • David C. Pratt Center
  • Nevada
    • Las Vegas, Nevada, United States, 89052
      • Comprehensive Cancer of Nevada
  • New York
    • Albany, New York, United States, 12208
      • New York Oncology Hematology - Albany Medical Center
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10065
      • Weill Cornell Medicine - Upper East Side
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Willamette Valley Cancer Institute and Research Center - Eugene
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology, PLLC
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
    • Tyler, Texas, United States, 75702
      • Texas Oncology - Tyler
  • Virginia
    • Blacksburg, Virginia, United States, 24060
      • Blue Ridge Cancer Care - Wytheville
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Regional Cancer Partnership

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sacituzumab Govitecan-hziy; Participants with non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), endometrial cancer, or metastatic small cell lung cancer (mSCLC) will receive sacituzumab govitecan-hziy 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle until disease progression (PD), toxicity or withdrawal of consent.	Drug: Sacituzumab Govitecan-hziy; Administered intravenously; Other Names: IMMU-132; GS-0132

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)		Up to 3 years
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities		Up to 3 years
Pharmacokinetic (PK) Parameter: Serum Concentration of Sacituzumab Govitecan-hziy		First dose date up to last dose date plus 30 days (up to 3 years)
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)

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 28, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Immunoconjugates; Sacituzumab govitecan
• Other Study ID Numbers: IMMU-132-11; 2019-000579-18 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No