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Trial record 1 of 1 for:    NCT03964727
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Study of Sacituzumab Govitecan-hziy in Metastatic Solid Tumors (TROPiCS-03)

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ClinicalTrials.gov Identifier: NCT03964727
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : August 4, 2021
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to to assess the objective response rate (ORR) of sacituzumab govitecan-hziy in adult participants with metastatic solid tumors.

Condition or disease Intervention/treatment Phase
Metastatic Solid Tumor Drug: Sacituzumab Govitecan-hziy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment [ Time Frame: Up to end of treatment (average 3 years) ]
    ORR, is defined as the rate of the overall best response, complete response (CR) or partial response (PR), based on the investigator-assessed tumor response using RECIST 1.1 criteria.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment [ Time Frame: Up to end of treatment (average 3 years) ]
    ORR, is defined as the rate of the overall best response, CR or PR, by BICR using RECIST 1.1 criteria

  2. Duration of Response (DOR) According to RECIST 1.1 by BICR [ Time Frame: Up to end of treatment (average 3 years) ]
    DOR, is calculated as the date of the first evaluation showing documented response, either PR or CR, to the date of the first progression of disease (PD) or death according to RECIST 1.1 by BICR

  3. Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR [ Time Frame: Up to end of treatment (average 3 years) ]
    CBR is defined as CR + PR + stable disease (SD) according to RECIST 1.1 by BICR

  4. Progression-free Survival (PFS) According to RECIST 1.1 by BICR [ Time Frame: Up to end of treatment (average 3 years) ]
    PFS, is defined as the time from first dose until objective tumor progression or death, whichever comes first according to RECIST 1.1 by BICR

  5. DOR According to RECIST 1.1 by Investigator's Assessment [ Time Frame: Up to end of treatment (average 3 years) ]
    DOR, is calculated as the date of the first evaluation showing documented response, either PR or CR, to the date of the first PD or death based on the investigator-assessed tumor response using RECIST 1.1 criteria

  6. Clinical Benefit Rate (CBR) According to RECIST 1.1 by Investigator's Assessment [ Time Frame: Up to end of treatment (average 3 years) ]
    CBR, is defined as CR + PR + SD based on the investigator-assessed tumor response using RECIST 1.1 criteria

  7. Progression-free Survival (PFS) According to RECIST 1.1 by Investigator's Assessment [ Time Frame: Up to end of treatment (average 3 years) ]
    PFS, is defined as the time from first dose until objective tumor progression or death, whichever comes first according to RECIST 1.1 based on the investigator-assessed tumor response using RECIST 1.1 criteria

  8. Trophoblast Cell-surface Antigen-2 (TROP-2) Expression Level [ Time Frame: Up to end of treatment (average 3 years) ]
  9. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) [ Time Frame: First dose date up to last dose date plus 30 days (average 3 years) ]
  10. Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) [ Time Frame: First dose date up to last dose date plus 30 days (average 3 years) ]
  11. Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities [ Time Frame: First dose date up to last dose date plus 30 days (average 3 years) ]
  12. Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab Govitecan-hziy [ Time Frame: First dose date up to last dose date plus 30 days (average 3 years) ]
    Cmax is defined as the maximum observed concentration of drug.

  13. Pharmacokinetic (PK) Parameter: AUC0-168h of Sacituzumab Govitecan-hziy [ Time Frame: First dose date up to last dose date plus 30 days (average 3 years) ]
    AUC0-168h is defined as the concentration of drug over time between time 0 and time 168 hours

  14. Pharmacokinetic (PK) Parameter: Tmax of Sacituzumab Govitecan-hziy [ Time Frame: First dose date up to last dose date plus 30 days (average 3 years) ]
    Tmax is defined as time to maximum observed concentration (Cmax)

  15. Immunogenicity Assessment [ Time Frame: First dose date up to last dose date plus 30 days (average 3 years) ]
    Number of participants who test positive for anti-drug antibodies to sacituzumab govitecan-hziy will be reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Able to understand and give written informed consent.
  • Individuals with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors. Tumor blocks (preferably, obtained within 12 months of study entry if clinically feasible) or 20 newly sectioned slides (6 minimum) of archived biopsy/surgical specimens are requested. these specimens should be submitted within 28 days before initiating Screening, after the individual provides written informed consent. A baseline biopsy is required if archival tissue is not available. Fine needle aspirations and bone biopsies are not suitable samples.

    • Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma (SCC)), that has progressed after prior platinum-based chemotherapy and Programmed death-ligand 1 (PD-L1) or Programmed cell death protein 1 (PD-1) directed therapy; recurrence/ relapse or lack of response within 6 months of completion of chemotherapy for locally advanced disease, that line of therapy may be counted for eligibility.
    • Incurable, recurrent, or metastatic HNSCC that has progressed after prior platinum based chemotherapy and PD-LI or PD-1 directed therapy
    • Relapsed unresectable endometrial cancer that has progressed after prior platinum based chemotherapy or is refractory to platinum based chemotherapy
  • 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 function
  • 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. Tumor lesions situated in a previously irradiated area may be utilized if they are considered measurable and progression has been demonstrated in such lesions.

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964727


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
Publications:

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03964727    
Other Study ID Numbers: IMMU-132-11
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms