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 (Actual): 227
• Phase: Phase 2

Contacts and Locations

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 Bergonie
  • Dijon, France, 21000
    • Centre George François Leclerc
  • Toulouse, France, 31059
    • Institut Claudius Regaud - 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, Taiwan
    • Changhua Christian Hospital
  • New Taipei City, Taiwan
    • Taipei TzuChi Hospital
  • Tainan, Taiwan
    • National Cheng Kung University Hospital
  • Tainan, Taiwan
    • Chi Mei Medical Center
  • Taoyuan, 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
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine - Siteman Cancer Center
    • St 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
    • 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
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 Group 1: NSCLC [Adenocarcinoma + Squamous Cell Carcinoma (SCC)]; Based on protocol amendment 1, participants with non-small cell lung cancer (NSCLC) subtypes such as adenocarcinoma and SCC with high trophoblast cell-surface antigen 2 (Trop-2) expression will receive sacituzumab govitecan-hziy (SG) 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.	Drug: Sacituzumab Govitecan-hziy; Administered intravenously; Other Names: IMMU-132; GS-0132
Experimental: Cohort 1 Group 2: NSCLC (Adenocarcinoma); Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.	Drug: Sacituzumab Govitecan-hziy; Administered intravenously; Other Names: IMMU-132; GS-0132
Experimental: Cohort 1 Group 3: NSCLC (SCC); Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.	Drug: Sacituzumab Govitecan-hziy; Administered intravenously; Other Names: IMMU-132; GS-0132
Experimental: Cohort 2: Head And Neck Squamous Cell Carcinoma (HNSCC); Participants with HNSCC will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.	Drug: Sacituzumab Govitecan-hziy; Administered intravenously; Other Names: IMMU-132; GS-0132
Experimental: Cohort 3: Endometrial Cancer (EC); Participants with EC will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.	Drug: Sacituzumab Govitecan-hziy; Administered intravenously; Other Names: IMMU-132; GS-0132
Experimental: Cohort 4: Extensive-Stage Small Cell Lung Cancer (ES-SCLC); Participants with ES-SCLC will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.	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 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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment	ORR was defined as the percentage of participants who had the best overall response of either CR or PR. Responses are based on BICR assessment using 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 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.	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
Duration of Response (DOR) According to RECIST 1.1 by BICR Assessment	DOR was the date of the first evaluation showing documented response, either PR or CR, to 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 for each histological 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 LD of target lesions, taking as reference the baseline sum LD. Disease progression was defined as an increase of >20% in the sum of diameters of target lesions, taking as reference the smallest sum on study(this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. DOR was estimated using Kaplan-Meier estimate. The 95% CI was computed by Brookmeyer-Crowley method.	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
Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR Assessment	CBR was percentage of participants with best overall response of CR, PR,or durable stable disease (SD) (SD ≥ 6 months after first dose). Responses are according to RECIST 1.1 by BICR.CR: Disappearance of all target and non-target lesions;& normalization of tumor marker levels initially above upper limits of normal;PR:>30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. SD:Neither sufficient shrinkage for PR nor sufficient increase for PD, taking reference of smallest sum LD since treatment started or ≥ 1 non-target lesions with maintenance of tumor marker level above normal limits.PD: Increase of >20% in sum of diameters of target lesions, taking reference of smallest sum(this includes baseline sum if smallest on study), the sum must also demonstrate an absolute increase of more than 5 mm or of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. Two-sided CI was based on Clopper-Pearson method.	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
Progression-free Survival (PFS) According to RECIST 1.1 by BICR Assessment	PFS was defined as the time from the first dose until objective tumor progression or death from any cause, whichever comes first. Responses are according to RECIST 1.1 by BICR. Disease progression was defined as an increase of >20% in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier estimate. The 95% CI for median was computed by Brookmeyer-Crowley method.	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
DOR According to RECIST 1.1 by Investigator's Assessment	DOR was the date of the first evaluation showing documented response, either PR or CR, to date of the first PD or death from any cause, whichever comes first. Responses are based on investigator-assessed tumor response by RECIST 1.1 criteria for each histological 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 LD of target lesions,taking as reference the baseline sum LD. Disease progression was defined as increase of >20% in sum of diameters of target lesions, taking as reference the smallest sum on study(this includes the baseline sum if that is the smallest on study).In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. DOR was estimated using Kaplan-Meier estimate. The 95% CI was computed by Brookmeyer-Crowley method.	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
CBR According to RECIST 1.1 by Investigator's Assessment	CBR was the percentage of participants with the best overall response of CR, PR,or durable SD (SD ≥ 6 months after first dose) by investigator-assessed tumor response using RECIST 1.1 criteria.CR:Disappearance of all target and non-target lesions;& normalization of tumor marker levels initially above upper limits of normal;PR:>30% decrease in sum of LD of target lesions,taking as reference the baseline sum LD. SD:Neither sufficient shrinkage for PR nor sufficient increase for PD,taking reference of smallest sum LD since treatment started or ≥ 1 non-target lesions with maintenance of tumor marker level above normal limits.PD: Increase of >20% in sum of diameters of target lesions,taking reference of smallest sum(this includes baseline sum if smallest on study),the sum must also demonstrate an absolute increase of more than 5 mm or of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions.Two-sided CI was based on Clopper-Pearson method.	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
PFS According to RECIST 1.1 by Investigator's Assessment	PFS was defined as the time from the 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. Disease progression was defined as an increase of >20% in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier estimate. The 95% CI for median was computed by Brookmeyer-Crowley method.	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
Overall Survival (OS)	OS was defined as the interval from the first dose date of drug to death from any cause. OS was estimated using Kaplan-Meier estimate. The 95% CI for median was computed by Brookmeyer-Crowley method.	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
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)	A TEAE was defined as any AE with an onset date on or after the study drug start date and no later than 30 days after last dose of study drug or the day before initiation of subsequent therapy, whichever comes first.	Up to 7.2 years
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities	A treatment-emergent laboratory abnormality was defined as any value that increased at least 1 toxicity grade from baseline during the treatment-emergent period.	Up to 7.2 years
Pharmacokinetic (PK) Parameter: Cmax of Total SN-38	Cmax was defined as the maximum observed concentration of total SN-38 (the active metabolite of sacituzumab Govitecan-hziy). Cycle length=21 days.	Cohort 1: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47; Cohort 2: Post dose: Day 1 of Cycles 1,2,3,7,11,17; Cohort 3: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47,53; Cohort 4: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29
PK Parameter: Cmax of Free SN-38	Cmax was defined as the maximum observed concentration of free SN-38 (the active metabolite of sacituzumab Govitecan-hziy). Cycle length=21 days.	Cohort 1: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47; Cohort 2: Post dose: Day 1 of Cycles 1,2,3,7,11,17; Cohort 3: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47,53; Cohort 4: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29
PK Parameter: Cmax of Total Antibody	Cmax was defined as the maximum observed concentration of total antibody of SG [hRS7 immunoglobulin (IgG) and hRS7-SN-38]. Cycle length=21 days.	Cohort 1: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47; Cohort 2: Post dose: Day 1 of Cycles 1,2,3,7,11,17; Cohort 3: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47,53; Cohort 4: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29
PK Parameter: Ctrough of Total SN-38	Ctrough was defined as concentration at the end of the dosing interval of total SN-38 (the active metabolite of sacituzumab Govitecan-hziy). Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)	C1:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,EOT(Upto 38.7months)&SFU;C2:PD,D1:Cycles1,2,3,7,11,17,EOT(Upto 12.3months)&SFU;C3:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,53,EOT(Upto 40.0months)&SFU;C4:PD,D1:Cycles1,2,3,7,11,17,23,29,EOT(Upto 29.3months)&SFU
PK Parameter: Ctrough of Free SN-38	Ctrough was defined as concentration at the end of the dosing interval of free SN-38 (the active metabolite of sacituzumab Govitecan-hziy). Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)	C1:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,EOT(Upto 38.7months)&SFU;C2:PD,D1:Cycles1,2,3,7,11,17,EOT(Upto 12.3months)&SFU;C3:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,53,EOT(Upto 40.0months)&SFU;C4:PD,D1:Cycles1,2,3,7,11,17,23,29,EOT(Upto 29.3months)&SFU
PK Parameter: Ctrough of Total Antibody	Ctrough was defined as concentration at the end of the dosing interval of total antibody of SG [hRS7 immunoglobulin (IgG) and hRS7-SN-38]. Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)	C1:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,EOT(Upto 38.7months)&SFU;C2:PD,D1:Cycles1,2,3,7,11,17,EOT(Upto 12.3months)&SFU;C3:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,53,EOT(Upto 40.0months)&SFU;C4:PD,D1:Cycles1,2,3,7,11,17,23,29,EOT(Upto 29.3months)&SFU
Percentage of Participants With Positive Anti-SG Antibodies	Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)	C1:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,EOT(Upto 38.7months)&SFU;C2:PD,D1:Cycles1,2,3,7,11,17,EOT(Upto 12.3months)&SFU;C3:PD,D1:Cycles1,2,3,7,11,17,23,29,35,41,47,53,EOT(Upto 40.0months)&SFU;C4:PD,D1:Cycles1,2,3,7,11,17,23,29,EOT(Upto 29.3months)&SFU

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Santin AD, Corr BR, Spira A, Willmott L, Butrynski J, Tse KY, Patel J, Mekan S, Wu T, Lin KW, Kuo P, Dumbrava EE. Efficacy and Safety of Sacituzumab Govitecan in Patients With Advanced Solid Tumors (TROPiCS-03): Analysis in Patients With Advanced Endometrial Cancer. J Clin Oncol. 2024 Oct 10;42(29):3421-3429. doi: 10.1200/JCO.23.02767. Epub 2024 Jul 31.
• Michel L, Jimeno A, Sukari A, Beck JT, Chiu J, Ahern E, Hilton J, Even C, Zanetta S, Mekan S, Patel J, Wu T, Dumbrava EE. Sacituzumab Govitecan in Patients with Relapsed/Refractory Advanced Head and Neck Squamous Cell Carcinoma: Results from the Phase II TROPiCS-03 Basket Study. Clin Cancer Res. 2025 Mar 3;31(5):832-838. doi: 10.1158/1078-0432.CCR-24-2523.
• Dowlati A, Chiang AC, Cervantes A, Babu S, Hamilton E, Wong SF, Tazbirkova A, Sullivan IG, van Marcke C, Italiano A, Patel J, Mekan S, Wu T, Waqar SN. Phase 2 Open-Label Study of Sacituzumab Govitecan as Second-Line Therapy in Patients With Extensive-Stage SCLC: Results From TROPiCS-03. J Thorac Oncol. 2025 Jun;20(6):799-808. doi: 10.1016/j.jtho.2024.12.028. Epub 2025 Jan 2.

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Actual): January 15, 2025
• Study Completion (Estimated): December 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 28, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Immunologic Factors; Physiological Effects of Drugs; Immunoconjugates; sacituzumab govitecan
• Other Study ID Numbers: IMMU-132-11; 2019-000579-18 (EudraCT Number); 2024-513611-28 (Other Identifier: European Medicines Agency)

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