Metastatic Solid TumorPhase 2TROPiCS-03NCT03964727
Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors
A Phase 2 study testing Sacituzumab Govitecan-hziy in people with Metastatic Solid Tumor, run by Gilead Sciences at 65 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumor
- What is being tested?
- Sacituzumab Govitecan-hziy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 65 sitesin 8 countries
- Study dates
- 15 Oct 2019to Dec 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
65 sites in 8 countries.
65 sites in 8 countries
United States31 sites
New York Oncology Hematology - Albany Medical Center
Albany, New York, 12208
Alaska Oncology & Hematology, LLC
Anchorage, Alaska, 99508
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, 80045
Blue Ridge Cancer Care - Wytheville
Blacksburg, Virginia, 24060
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Karmanos Cancer Institute
Detroit, Michigan, 48201
Willamette Valley Cancer Institute and Research Center - Eugene
Eugene, Oregon, 97401
Providence Regional Cancer Partnership
Everett, Washington, 98201
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
PathGroup Labs, LLC
Fort Wayne, Indiana, 46804
Parkview Research Center
Fort Wayne, Indiana, 46845
USOR - Arizona Oncology - Glendale - Saguaro Cancer Center
Glendale, Arizona, 85308
Arizona Oncology Associates PC-HAL
Goodyear, Arizona, 85395
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Comprehensive Cancer of Nevada
Las Vegas, Nevada, 89052
University of Kentucky Medical Center
Lexington, Kentucky, 40536
UCLA Hematology/Oncology
Los Angeles, California, 90095
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Smilow Cancer Hospital at Yale
New Haven, Connecticut, 06520
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medicine - Upper East Side
New York, New York, 10065
Christus Highland Cancer Treatment Center
Shreveport, Louisiana, 71105
Highlands Oncology Group
Springdale, Arkansas, 72762
SIU School of Medicine, Simmons Cancer Institute at SIU
Springfield, Illinois, 62702
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
David C. Pratt Center
St Louis, Missouri, 63141
Montefiore Medical Center
The Bronx, New York, 10467
North Mississippi Medical Center - Hematology and Oncology - Tupelo
Tupelo, Mississippi, 38801
Texas Oncology - Tyler
Tyler, Texas, 75702
TRIO-US Central Administration
Whittier, California, 90602
Australia9 sites
Pindara Private Hospital
Benowa, Queensland, 4217
Southern Highlands Cancer Center
Bowral, New South Wales, 2576
Monash Medical Centre, Monash Health
Clayton, Victoria, 3168
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
The Andrew Love Cancer Centre, Geelong Hospital
Geelong, Victoria, 3220
Macquarie University
North Ryde, New South Wales, 2109
Mater Cancer Centre, Mater Misericordiae Limited
South Brisbane, Queensland, 4101
Calvary Mater Newcastle Hospital
Waratah, New South Wales, 2298
Blacktown Hospital
Westmead, New South Wales, 2145
Hong Kong5 sites
Hong Kong Integrated Oncology Centre
Central
Hong Kong Sanatorium & Hospital
Happy Valley
Queen Mary Hospital
Hong Kong
Hong Kong United Oncology Center
Kowloon
Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital
Shatin
Spain5 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Institut Català d'Oncologia
Barcelona, 08908
Hospital Universitari Vall d'Hebron
Barcelona, 8035
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Clínico Universitario de Valencia
Valencia, 46010
Taiwan5 sites
Changhua Christian Hospital
Changhua
Taipei TzuChi Hospital
New Taipei City
Chi Mei Medical Center
Tainan
National Cheng Kung University Hospital
Tainan
Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
Taoyuan City, 33305
Canada4 sites
Cross Cancer Institute
Edmonton, T6G 1Z2
London Health Sciences Centre- Victoria Hospital
London, N6A 5W9
Jewish General Hospital
Montreal, H3T 1E2
The Ottawa Hospital
Ottawa, K1H 8L6
France4 sites
Institut Bergonie
Bordeaux, 33000
Centre George Francois Leclerc
Dijon, 21000
Institut Claudius Régaud - IUCT Oncopole
Toulouse, 31059
Institut Gustave Roussy
Villejuif, 94805
Belgium2 sites
Cliniques Universitaires UCL Saint-Luc
Brussels, 1200
Grand Hopital de Charleroi asbl (GHdC)
Charleroi, 6000
About this study
Official title: 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.
- Conditions
- Metastatic Solid Tumor
- Being tested
- Sacituzumab Govitecan-hziy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab Govitecan-hziyDrug
Also called IMMU-132, GS-0132
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Group 1: NSCLC [Adenocarcinoma + Squamous Cell Carcinoma (SCC)] | Experimental | 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. Receives: Drug: Sacituzumab Govitecan-hziy |
| Cohort 1 Group 2: NSCLC (Adenocarcinoma) | Experimental | 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. Receives: Drug: Sacituzumab Govitecan-hziy |
| Cohort 1 Group 3: NSCLC (SCC) | Experimental | 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. Receives: Drug: Sacituzumab Govitecan-hziy |
| Cohort 2: Head And Neck Squamous Cell Carcinoma (HNSCC) | Experimental | 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. Receives: Drug: Sacituzumab Govitecan-hziy |
| Cohort 3: Endometrial Cancer (EC) | Experimental | 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. Receives: Drug: Sacituzumab Govitecan-hziy |
| Cohort 4: Extensive-Stage Small Cell Lung Cancer (ES-SCLC) | Experimental | 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. Receives: Drug: Sacituzumab Govitecan-hziy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start15 Oct 2019
- Primary completion15 Jan 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metastatic Solid TumorStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964727
- Sponsor's protocol ID
- IMMU-132-11
- Other IDs
- 2019-000579-18, 2024-513611-28, 2019
- Acronym
- TROPiCS-03
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2019
- Last updated
- 28 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39083724Michel 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.
PubMed 39665770Dowlati 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.
PubMed 39755168
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT03964727
- Acronym / sponsor ID
- TROPiCS-03 / IMMU-132-11
- Conditions
- Metastatic Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 May 2019 (actual)
- Results
- Posted 30 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Group 1: NSCLC [Adenocarcinoma + Squamous Cell Carcinoma (SCC)] | Experimental | Drug: Sacituzumab Govitecan-hziyBased 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. |
| Cohort 1 Group 2: NSCLC (Adenocarcinoma) | Experimental | Drug: Sacituzumab Govitecan-hziyBased 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. |
| Cohort 1 Group 3: NSCLC (SCC) | Experimental | Drug: Sacituzumab Govitecan-hziyBased 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. |
| Cohort 2: Head And Neck Squamous Cell Carcinoma (HNSCC) | Experimental | Drug: Sacituzumab Govitecan-hziyParticipants 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. |
| Cohort 3: Endometrial Cancer (EC) | Experimental | Drug: Sacituzumab Govitecan-hziyParticipants 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. |
| Cohort 4: Extensive-Stage Small Cell Lung Cancer (ES-SCLC) | Experimental | Drug: Sacituzumab Govitecan-hziyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Individuals with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab Govitecan-hziyAlso: IMMU-132, GS-0132Administered intravenously | Drug | Cohort 1 Group 1: NSCLC [Adenocarcinoma + Squamous Cell Carcinoma (SCC)], Cohort 1 Group 2: NSCLC (Adenocarcinoma), Cohort 1 Group 3: NSCLC (SCC), Cohort 2: Head And Neck Squamous Cell Carcinoma (HNSCC), Cohort 3: Endometrial Cancer (EC), Cohort 4: Extensive-Stage Small Cell Lung Cancer (ES-SCLC) |
Primary outcome
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment
Time frame: 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.
17 secondary outcomes
ORR According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Up to 7.2 years
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
Time frame: Up to 7.2 years
Pharmacokinetic (PK) Parameter: Cmax of Total SN-38
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 39083724Santin 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.
- Background: PubMed 39665770Michel 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.
- Background: PubMed 39755168Dowlati 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.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
65 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab Govitecan-hziy in people with Metastatic Solid Tumor, run by Gilead Sciences at 65 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Australia, Hong Kong, Spain, Taiwan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03964727, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.