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A Study of Sacituzumab Govitecan in Metastatic Solid Tumors (TROPICS-03)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964727
Recruitment Status : Suspended (The study has been halted temporarily to mitigate the impact of the COVID-19 pandemic)
First Posted : May 28, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.

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 with elevated Trop-2 expression.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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 : April 2022
Estimated Study Completion Date : August 2022

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. Objective Response Rate [ Time Frame: through study completion, an average of 6 months ]
    Assess the objective response rate (ORR) of sacituzumab govitecan in subjects with metastatic solid tumors enriched for Trop-2 expression by investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) according to RECIST 1.1 by BICR assessment [ Time Frame: every 6 weeks from Cyle1 Day 1 for an average of 6 months, each cycle is 21 days ]
    Overall Response Rate (ORR) , according to RECIST 1.1 by BICR assement

  2. Assess the Safety Pharmacokinetics of hRS7-IgG & hRS&-SN38 [ Time Frame: through treatment completion, an average of 6 months ]
    Area under the plasma/serum/blood drug concentration-time curve (AUC) from time zero to the time of the last quantifiable concentration of hRS7-IgG & hRS7-SN38

  3. Assess the Plasma Concentration of hRS7-IgG & hRS&-SN38 [ Time Frame: through treatment completion, an average of 6 months ]
    Maximum Plasma Concentration (Cmax) of hRS7-IgG & hRS7-SN38 from time zero to the time of the last quantifiable concentration of hRS7-IgG & hRS7-SN38

  4. Assess the Time of Peak Concentration of hRS7-IgG & hRS&-SN38 [ Time Frame: through treatment completion, an average of 6 months ]
    Time to Peak Concentration (Tmax) of hRS7-IgG & hRS7-SN38 from time zero to the time of the last quantifiable concentration of hRS7-IgG & hRS7-SN38

  5. Assess the AUCinf of hRS7-IgG & hRS&-SN38 [ Time Frame: through treatment completion, an average of 6 months ]
    Area under the plasma concentration versus time curve from zero to infinity of hRS7-IgG & hRS7-SN38

  6. Assess the CL/f of hRS7-IgG & hRS&-SN38 [ Time Frame: through treatment completion, an average of 6 months ]
    Clearance/Bioavailability of hRS7-IgG & hRS7-SN38

  7. Assess the t1/2 of hRS7-IgG & hRS&-SN38 [ Time Frame: through treatment completion, an average of 6 months ]
    Terminal half life of hRS7-IgG & hRS7-SN38

  8. Immunogenicity by ADA [ Time Frame: through treatment completion, an average of 6 months ]
    Assess the Immunogenicity of Sacituzumab-Govitecan by Anti-Drug Assay (ADA)



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 (adenocarcinoma or SCC), that has progressed after one line of 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.
  • 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:

  • Hepatitis B/C
  • Has 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.
  • 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


Locations
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United States, Arizona
Arizona Oncology
Phoenix, Arizona, United States, 85016
United States, California
University of California San Diego Moores Cancer Center
La Jolla, California, United States, 92093
United States, Colorado
University of Colorado Hospital Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
Miami Cancer Institute
Miami, Florida, United States, 33176
United States, Michigan
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, United States, 48201
United States, Mississippi
North Mississippi Medical Centers
Tupelo, Mississippi, United States, 33801
United States, Missouri
Washington University School of Medicine in Saint Louis
Saint Louis, Missouri, United States, 63110
United States, Nevada
Comprehensive Cancer Centers of Nevada- Henderson
Las Vegas, Nevada, United States, 89052
United States, New York
New York Oncology Hematology - Albany Medical Center
Albany, New York, United States, 12208
Memorial Sloan Kettering
New York, New York, United States, 10022
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, Oregon
Willamette Valley Cancer Institute and Research Center - Eugene
Eugene, Oregon, United States, 97401
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Immunomedics, Inc.
Investigators
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Study Chair: Cabilia Pichardo, MD Immunomedics, Inc.
Publications:

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Responsible Party: Immunomedics, Inc.
ClinicalTrials.gov Identifier: NCT03964727    
Other Study ID Numbers: Immu-132-11
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: December 2019

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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
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Head and Neck Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms