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    Summary
    EudraCT Number:2019-000579-18
    Sponsor's Protocol Code Number:IMMU-132-11
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-04-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2019-000579-18
    A.3Full title of the trial
    A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects with Metastatic Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Sacituzumab Govitecan (IMMU-132) in Subjects with Metastatic Solid Tumors
    A.3.2Name or abbreviated title of the trial where available
    TROPICS-03
    A.4.1Sponsor's protocol code numberIMMU-132-11
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03964727
    A.5.4Other Identifiers
    Name:IND numberNumber:115621
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGilead Sciences, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressGilead Sciences, Flowers Building
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223 897284
    B.5.6E-mailclinical.trials@gilead.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Trodelvy
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences Ireland UC
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namesacituzumab govitecan
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSACITUZUMAB GOVITECAN
    D.3.9.2Current sponsor codeIMMU-132
    D.3.9.4EV Substance CodeSUB191213
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Solid Tumors
    E.1.1.1Medical condition in easily understood language
    Metastatic Solid Tumors
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the ORR of sacituzumab govitecan in subjects with metastatic solid tumors by Investigator’s assessment according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria.
    E.2.2Secondary objectives of the trial
    - Assess the ORR, duration of response (DOR), clinical benefit rate (CBR), and progression-free survival (PFS) of sacituzumab govitecan in subjects with metastatic solid tumors by blinded independent central review (BICR) according to RECIST 1.1 criteria.
    - Assess the DOR, CBR, and PFS of sacituzumab govitecan in subjects with metastatic solid tumors by Investigator’s assessment according to RECIST 1.1 criteria.
    - Assess the OS of sacituzumab govitecan in subjects with metastatic solid tumors.
    - Assess the safety of sacituzumab govitecan in subjects with metastatic solid tumors.
    - Assess the PK and immunogenicity of sacituzumab govitecan in subjects with metastatic solid tumors.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects meeting all the following inclusion criteria at Screening will be eligible for participation in the study.
    1) Female or male subjects, > 18 years of age, who are able to understand and give written informed consent.
    2) Subjects with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors.
    a) NSCLC (adenocarcinoma or SCC) that has progressed after prior platinum-based chemotherapy and programmed death-(ligand) 1 (PD-(L)1) directed therapy given sequentially (in either order) or in combination. These agents could have been taken as monotherapy or in combination with other agents. If subjects have had recurrence/relapse or lack of response within 6 months of completing chemotherapy with or without PD-(L)1 directed therapy for locally advanced disease, that line of therapy may be counted for eligibility.
    b) HNSCC that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy given sequentially (in either order) or in combination. These agents
    could have been taken as monotherapy or in combination with other agents. No more than 3 prior lines of systemic treatment is allowed.
    c) Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and anti- PD-(L)1 directed therapy given sequentially (in either order) or in combination. These agents could have been taken as monotherapy or in combination with other agents. No more than 3 prior lines of systemic treatment is allowed. Endometrial carcinoma with any histology including microsatellite instability-high /mismatch repair deficient and microsatellite stable (MSI-h/dMMR and MSS) are
    allowed.
    d) 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).
    3) ECOG Performance Status score of 0 or 1.
    4) Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count
    (ANC) ≥ 1,500/mm3, and platelets ≥ 100,000/μL).
    5) Adequate hepatic function (bilirubin ≤ 1.5 institutional upper limit of normal [IULN], aspartate aminotransferase [AST], and alanine aminotransferase [ALT] ≤ 2.5 × IULN or
    ≤ 5 × IULN if known liver metastases and serum albumin > 3 g/dL).
    6) Creatinine clearance ≥ 30 mL/min as assessed by Cockcroft-Gault.
    7) Subjects must have at least a 3-month life expectancy.
    8) Have measurable disease by CT or MRI scan as per RECIST 1.1 criteria. Tumor lesions situated in a previously irradiated area may be utilized if they are considered measurable and PD has been demonstrated in such lesions.
    9) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
    10) Tumor blocks (preferably obtained within 12 months of study entry if clinically feasible) or 20 newly sectioned unstained slides (6 slides minimum) of archived biopsy/surgical specimens are requested. A baseline biopsy is required if archival tissue is not available. Fine needle aspirates and bone biopsies are not suitable samples. These specimens should be submitted within the 28-day screening period, after the subject provides written informed consent.
    E.4Principal exclusion criteria
    Subjects meeting any of the following exclusion criteria at Screening will not be enrolled in the study.
    1) Positive serum pregnancy test (Appendix 17.5) or women who are lactating.
    2) Are currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to the first dose of study drug.
    Subjects participating in observational studies are eligible.
    3) 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, or radiation therapy within
    2 weeks prior to study Day 1.
    4) Have not recovered (ie, ≤ Grade 1) from AEs due to a previously administered agent.
    5) Have previously received topoisomerase I inhibitors (for SCLC cohort: Etoposide with platinum combination in first-line setting is allowed).
    6) Have an active second malignancy.
    7) Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects 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, no evidence of new or enlarging brain
    metastases and are taking ≤ 20 mg/day of prednisone or its equivalent. All subjects with carcinomatous meningitis are excluded regardless of clinical stability.
    8) Have active cardiac disease, defined as:
    - Myocardial infarction or unstable angina pectoris within 6 months of Day 1.
    - History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication); history of QT interval prolongation.
    - New York Heart Association (NYHA) Class III or greater congestive heart failure or
    left ventricular ejection fraction of < 40%.
    9) Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease), immune-mediated colitis, or gastrointestinal (GI) perforation within 6 months of C1D1.
    10) Have an active infection requiring IV antibiotics.
    11) Have positive human immunodeficiency virus (HIV)-1 or HIV-2 antibody with detectable viral load or taking medications that may interfere with SN-38 (the active metabolite of
    sacituzumab govitecan).
    12) Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), subjects with a detectable viral load will be excluded.
    - Subjects who test positive for hepatitis B surface antigen (HBsAg). Subjects who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease.
    - Subjects who test positive for HCV antibody. Subjects who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Subjects with a known history of HCV or a positive HCV antibody test will not require an HCV antibody at screening and will only require HCV RNA by quantitative PCR for confirmation of active disease.
    13) Have other concurrent medical or psychiatric conditions that, in the Investigator’s opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
    14) Impending need for palliative radiation therapy or surgery for pathological fractures and/or for medullary compression within 4 weeks prior to initiating study treatment.
    15) Additional cohort-specific exclusion criteria:
    - NSCLC cohort (adenocarcinoma and SCC):
    a) Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc); any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren syndrome, sarcoidosis, etc); or prior pneumonectomy.
    - HNSCC cohort:
    b) Subjects with nasopharynx carcinoma.
    c) Subjects who had progressive disease within 6 months of completion of curative therapy.
    - Endometrial carcinoma cohort:
    d) Subjects who have carcinosarcoma (malignant mixed Mullerian tumor), endometrial leiomyosarcoma, and/or endometrial stromal sarcomas.
    - Small cell lung cancer cohort:
    e) Subjects who never received platinum-containing regimen for SCLC.
    f) Limited-stage subjects who are candidates for local or regional therapy.
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR) according to RECIST 1.1 by Investigator’s assessment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study.
    E.5.2Secondary end point(s)
    - ORR, DOR, CBR, and PFS according to RECIST 1.1 by BICR.
    - DOR, CBR, and PFS, according to RECIST 1.1 by Investigator’s assessment.
    - Overall survival (OS).
    - Incidence of treatment-emergent adverse events (AEs) and clinical laboratory abnormalities.
    - Serum concentrations of sacituzumab govitecan over time and incidence of anti-drug antibody (ADA) to sacituzumab govitecan.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Hong Kong
    Taiwan
    Australia
    Canada
    United Kingdom
    United States
    Belgium
    France
    Spain
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the entire study for all subjects is defined as the date on which the last subject remaining on study completes the last study visit/call/survival follow-up or when the Sponsor decides to end the study. The Sponsor reserves the right to terminate the study at any time for any reason (including safety).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 210
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 210
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 420
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    At the completion of the study, subjects who were deriving benefit from sacituzumab govitecan may continue to receive treatment in a rollover study (Study IMMU-132-14) in locations where the study is available.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-29
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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