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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 : May 13, 2022
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is 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 : 165 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 : August 2023
Estimated Study Completion Date : February 2025

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 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.
Drug: Sacituzumab Govitecan-hziy
Administered intravenously
Other Names:
  • IMMU-132
  • GS-0132




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 3 years ]
    ORR, is defined as the proportion of participants who achieve the best overall response, confirmed complete response (CR) or partial response (PR). Responses are based on the investigator-assessed tumor response using RECIST 1.1 criteria.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment [ Time Frame: Up to 3 years ]
    ORR, is defined as the proportion of participants who achieve the best overall response, confirmed CR or PR. Responses are based on BICR assessment using RECIST 1.1 criteria.

  2. Duration of Response (DOR) According to RECIST 1.1 by BICR [ Time Frame: Up to 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 from any cause, whichever comes first. Response are according to RECIST 1.1 by BICR

  3. Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR [ Time Frame: Up to 3 years ]
    CBR is defined as the proportion of participants who achieve the best overall response, CR + PR + stable disease (SD). Responses are according to RECIST 1.1 by BICR.

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

  5. DOR According to RECIST 1.1 by Investigator's Assessment [ Time Frame: Up to 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 from any cause, whichever comes first. Responses are 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 3 years ]
    CBR, is defined as the proportion of participants who achieve the best overall response, CR + PR + SD. Responses are 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 3 years ]
    PFS, is defined as the time from 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.

  8. Overall Survival (OS) [ Time Frame: Up to 3 years ]
    Overall survival is defined as the interval from the first dose date of drug to death from any cause.

  9. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) [ Time Frame: Up to 3 years ]
  10. Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities [ Time Frame: Up to 3 years ]
  11. Pharmacokinetic (PK) Parameter: Serum Concentration of Sacituzumab Govitecan-hziy [ Time Frame: First dose date up to last dose date plus 30 days (up to 3 years) ]
  12. Immunogenicity Assessment [ Time Frame: First dose date up to last dose date plus 30 days (up to 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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 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.


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
Additional Information:
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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: May 13, 2022
Last Verified: May 2022
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