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A Study of Sacituzumab Govitecan 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 : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU0132) in Subjects With Metastatic Solid Tumors

Condition or disease Intervention/treatment Phase
Metastatic Non-Small Cell Lung Carcinoma Head and Neck Squamous Cell Carcinoma Endometrial Cancer Biological: IMMU-132 Phase 2

Detailed Description:
This is a multi-cohort, open-label, Phase 2 study designed to assess the clinical activity of sacituzumab govitecan in adult subjects with metastatic solid tumors.

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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 : August 6, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IMMU-132
IMMU-132/Sacituzumab govitecan will be administered at 10 mg/kg as an intravenous infusion on days 1 and 8 of a 21-day cycle until disease progression (PD), toxicity or withdrawal of consent.
Biological: IMMU-132
Sacituzumab govitecan will be administered at 10 mg/kg as an intravenous infusion on days 1 and 8 of a 21-day cycle until disease progression (PD), toxicity or withdrawal of consent.
Other Name: sacituzumab govitecan




Primary Outcome Measures :
  1. 1. Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment [ Time Frame: up to study completion, (average 32 months) ]
    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. 2. Overall Response Rate (ORR) According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment [ Time Frame: every 6 weeks from Cyle1 Day 1 for an average of 3 years, each cycle is 21 days ]
    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 Study Completion (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 6 months ]
    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 Study Completion (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 Study Completion (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. CBR According to RECIST 1.1 by Investigator's Assessment [ Time Frame: Up to Study Completion (average 3 years) ]
    CBR, is defined as CR + PR + SD based on the investigator-assessed tumor response using RECIST 1.1 criteria

  7. PFS According to RECIST 1.1 by Investigator's Assessment [ Time Frame: Up to Study Completion (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 Study Completion (average 3 years) ]
    Trophoblast Cell-surface Antigen-2 (TROP-2) Expression Level

  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 ]
    Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)

  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) ]
    Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs

  11. Percentage of Participants with Clinically Significant Laboratory Changes [ Time Frame: First dose date up to last dose date plus 30 days (average: 3 years) ]
    Percentage of Participants with Clinically Significant Laboratory Changes

  12. Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab-Govitecan [ Time Frame: Up to Study Completion (average 3 years) and at 30-Day Safety Follow-up Visit. ]
    Cmax is defined as the maximum observed concentration of drug.

  13. Pharmacokinetic (PK) Parameter: AUC0-168h of Sacituzumab-Govitecan [ Time Frame: Up to Study Completion (average 3 years) and at 30-Day Safety Follow-up Visit ]
    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 [ Time Frame: Up to Study Completion (average 3 years) and at 30-Day Safety Follow-up Visit ]
    Tmax is defined as time to maximum observed concentration

  15. Immunogenicity Assessment [ Time Frame: Up to Study Completion (average 3 years) and at 30-Day Safety Follow-up Visit ]
    Number of participants who test positive for anti-drug antibodies to Sacituzumab-Govitecan 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

Inclusion Criteria:

  • Female or male subjects, at least 18 years of age, able to understand and give written informed consent.
  • Subjects with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors. NSCLC. 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 subject 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.

NSCLC (adenocarcinoma or SCC), that has progressed after prior platinum-based chemotherapy and PD-L1 or 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. Relapsed unresectable endometrial cancer that has progressed after prior platinum-based chemotherapy or is refractory to platinum-based chemotherapy.

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 refactory to platinum based chemotherapy

  • Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1 (see Appendix 1)
  • Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation
  • Adequate hepatic function
  • Subject 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 (see Appendix 4). Tumor lesions situated in a previously irradiated area may be utilized if they are considered measurable and progression has been demonstrated in such lesions.

Exclusion Criteria:

Has has 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. 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, have 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

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: Immunomedics Medical Information 888-983-4668 MedInfo@Immunomedics.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Chair: Cabilia Pichardo, MD 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: April 13, 2021
Last Verified: April 2021

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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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Carcinoma
Endometrial Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Head and Neck Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms