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TROPiCS-03: Study of Sacituzumab Govitecan-hziy in Metastatic Solid Tumors

Sponsor
Gilead Sciences (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03964727
Collaborator
(none)
165
Enrollment
39
Locations
1
Arm
63.6
Anticipated Duration (Months)
4.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Sacituzumab Govitecan-hziy
 Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 15, 2019
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment [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 [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 [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 [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 [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 [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 [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 [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) [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) [Up to 3 years]

    10. Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities [Up to 3 years]

    11. Pharmacokinetic (PK) Parameter: Serum Concentration of Sacituzumab Govitecan-hziy [First dose date up to last dose date plus 30 days (up to 3 years)]

    12. Immunogenicity Assessment [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alaska Oncology & Hematology, LLC Anchorage Alaska United States 99508
    2 USOR - Arizona Oncology - Glendale - Saguaro Cancer Center Glendale Arizona United States 85308
    3 Arizona Oncology Associates PC-HAL Goodyear Arizona United States 85395
    4 Highlands Oncology Group Springdale Arkansas United States 72762
    5 Los Angeles Hematology Oncology Medical Group Los Angeles California United States 90017
    6 University of Colorado Hospital - Anschutz Cancer Pavilion Aurora Colorado United States 80045
    7 Smilow Cancer Hospital at Yale New Haven Connecticut United States 06520
    8 Miami Cancer Institute at Baptist Health, Inc. Miami Florida United States 33176
    9 Parkview Research Center Fort Wayne Indiana United States 46845
    10 University of Kentucky Medical Center Lexington Kentucky United States 40536
    11 Christus Highland Cancer Treatment Center Shreveport Louisiana United States 71105
    12 University of Michigan Rogel Cancer Center Ann Arbor Michigan United States 48109
    13 Karmanos Cancer Institute Detroit Michigan United States 48201
    14 North Mississippi Medical Center - Hematology and Oncology - Tupelo Tupelo Mississippi United States 38801
    15 Washington University School of Medicine - Siteman Cancer Center Saint Louis Missouri United States 63110
    16 David C. Pratt Center Saint Louis Missouri United States 63141
    17 Comprehensive Cancer of Nevada Las Vegas Nevada United States 89052
    18 New York Oncology Hematology - Albany Medical Center Albany New York United States 12208
    19 Montefiore Medical Center Bronx New York United States 10467
    20 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    21 Weill Cornell Medicine - Upper East Side New York New York United States 10065
    22 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    23 Willamette Valley Cancer Institute and Research Center - Eugene Eugene Oregon United States 97401
    24 Tennessee Oncology, PLLC Nashville Tennessee United States 37203
    25 The University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    26 Texas Oncology - Tyler Tyler Texas United States 75702
    27 Blue Ridge Cancer Care - Wytheville Blacksburg Virginia United States 24060
    28 Virginia Cancer Specialists, PC Fairfax Virginia United States 22031
    29 Calvary Mater Newcastle Hospital Waratah New South Wales Australia 2298
    30 Blacktown Hospital Westmead New South Wales Australia 2145
    31 Pindara Private Hospital Benowa Queensland Australia 4217
    32 The Andrew Love Cancer Centre, Geelong Hospital Geelong Victoria Australia 3220
    33 Hong Kong Integrated Oncology Centre Central Hong Kong
    34 Hong Kong Sanatorium & Hospital Happy Valley Hong Kong
    35 Queen Mary Hospital Hong Kong Hong Kong
    36 Hong Kong United Oncology Center Kowloon Hong Kong
    37 Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital Shatin Hong Kong
    38 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08041
    39 Taipei TzuChi Hospital New Taipei City Taiwan

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT03964727
    Other Study ID Numbers:
    • IMMU-132-11
    First Posted:
    May 28, 2019
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Aug 9, 2022