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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03964727




Registration number
NCT03964727
Ethics application status
Date submitted
29/04/2019
Date registered
28/05/2019

Titles & IDs
Public title
Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors
Scientific title
A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors
Secondary ID [1] 0 0
2019-000579-18
Secondary ID [2] 0 0
IMMU-132-11
Universal Trial Number (UTN)
Trial acronym
TROPiCS-03
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sacituzumab Govitecan-hziy

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.


Treatment: Drugs: Sacituzumab Govitecan-hziy
Administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Objective Response Rate (ORR) According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Duration of Response (DOR) According to RECIST 1.1 by BICR
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Progression-free Survival (PFS) According to RECIST 1.1 by BICR
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
DOR According to RECIST 1.1 by Investigator's Assessment
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [6] 0 0
Clinical Benefit Rate (CBR) According to RECIST 1.1 by Investigator's Assessment
Timepoint [6] 0 0
Up to 3 years
Secondary outcome [7] 0 0
Progression-free Survival (PFS) According to RECIST 1.1 by Investigator's Assessment
Timepoint [7] 0 0
Up to 3 years
Secondary outcome [8] 0 0
Overall Survival (OS)
Timepoint [8] 0 0
Up to 3 years
Secondary outcome [9] 0 0
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
Timepoint [9] 0 0
Up to 3 years
Secondary outcome [10] 0 0
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
Timepoint [10] 0 0
Up to 3 years
Secondary outcome [11] 0 0
Pharmacokinetic (PK) Parameter: Serum Concentration of Sacituzumab Govitecan-hziy
Timepoint [11] 0 0
First dose date up to last dose date plus 30 days (up to 3 years)
Secondary outcome [12] 0 0
Immunogenicity Assessment
Timepoint [12] 0 0
First dose date up to last dose date plus 30 days (up to 3 years)

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
165
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Southern Highlands Cancer Center - Bowral
Recruitment hospital [2] 0 0
Macquarie University - North Ryde
Recruitment hospital [3] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment hospital [4] 0 0
Blacktown Hospital - Westmead
Recruitment hospital [5] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [6] 0 0
Mater Cancer Centre, Mater Misericordiae Limited - South Brisbane
Recruitment hospital [7] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [8] 0 0
Monash Medical Centre, Monash Health - Clayton
Recruitment hospital [9] 0 0
The Andrew Love Cancer Centre, Geelong Hospital - Geelong
Recruitment postcode(s) [1] 0 0
2576 - Bowral
Recruitment postcode(s) [2] 0 0
2109 - North Ryde
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4217 - Benowa
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Belgium
State/province [22] 0 0
Brussels
Country [23] 0 0
Belgium
State/province [23] 0 0
Charleroi
Country [24] 0 0
Canada
State/province [24] 0 0
Edmonton
Country [25] 0 0
Canada
State/province [25] 0 0
London
Country [26] 0 0
Canada
State/province [26] 0 0
Montreal
Country [27] 0 0
Canada
State/province [27] 0 0
Ottawa
Country [28] 0 0
France
State/province [28] 0 0
Bordeaux
Country [29] 0 0
France
State/province [29] 0 0
Dijon
Country [30] 0 0
France
State/province [30] 0 0
Toulouse
Country [31] 0 0
France
State/province [31] 0 0
Villejuif
Country [32] 0 0
Hong Kong
State/province [32] 0 0
Central
Country [33] 0 0
Hong Kong
State/province [33] 0 0
Happy Valley
Country [34] 0 0
Hong Kong
State/province [34] 0 0
Hong Kong
Country [35] 0 0
Hong Kong
State/province [35] 0 0
Kowloon
Country [36] 0 0
Hong Kong
State/province [36] 0 0
Shatin
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
Spain
State/province [39] 0 0
Valencia
Country [40] 0 0
Taiwan
State/province [40] 0 0
Changhua City
Country [41] 0 0
Taiwan
State/province [41] 0 0
New Taipei City
Country [42] 0 0
Taiwan
State/province [42] 0 0
Tainan City
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taoyuan City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03964727