Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date  ICMJE April 29, 2019
First Posted Date  ICMJE May 28, 2019
Last Update Posted Date March 25, 2020
Actual Study Start Date  ICMJE August 6, 2019
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
Objective Tumor Response Rates as assessed by RECIST 1.1 by Investigator Assessment [ Time Frame: through study completion, an average of 6 months ]
Assess the clinical activity of sacituzumab govitecan in subjects with metastatic solid tumors according to objective tumor response rates through study completion, an average of 6 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Immunogenicity by ADA [ Time Frame: through treatment completion, an average of 6 months ]
    Assess the Immunogenicity of Sacituzumab-Govitecan by Anti-Drug Assay (ADA)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • Overall Response Rate (ORR) according to RECIST 1.1 by BICR and Investigator assessed [ Time Frame: every 6 weeks from Cyle1 Day 1 for 12 cycles (approximately 9 months) and then every 9 weeks until disease progression, study completion or up to approximately 2 years ]
    Overall Response Rate (ORR) , according to RECIST 1.1 by BICR and Investigator Assessment
  • Duration of Response (DUR) according to RECIST 1.1 by BICR and Investigator assessed [ Time Frame: Every 6 weeks from Cyle1 Day 1 for 12 cycles (approximately 9 months) and then every 9 weeks until disease progression, study completion or up to approximately 2 years ]
    Duration Of Response (DUR) according to RECIST 1.1 by BICR and Investigator Assessment
  • Progression free Survival (PFS) according to RECIST 1.1 by BICR and Investigator assessed [ Time Frame: Every 6 weeks from Cyle1 Day 1 for 12 cycles (approximately 9 months) and then every 9 weeks until disease progression, study completion or up to approximately 2 years ]
    Progression Free Survival (PFS) according to RECIST 1.1 by BICR and Investigator Assessment
  • Assess safety evaluated by adverse events and serious adverse events as assessed by CTCAE v.5.0 [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Assess the safety evaluated by adverse events and serious adverse events
  • Assess Safety as evaluated by blood pressure ( in mm/hg) [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Assess Safety as evaluated by blood pressure ( in mm/hg)
  • Assess Safety as evaluated by heart rate (beats per minute) [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Assess Safety as evaluated by heart rate (beats per minute)
  • Assess Safety as evaluated by respiratory rate (breaths per minute) [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Assess Safety as evaluated by respiratory rate (breaths per minute)
  • Assess Safety as evaluated by body temperature (Celsius) [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Asess Safety as evaluated by body temperature (Celsius)
  • Assess Safety as assessed by laboratory changes in complete blood count (CBC) (including white blood cell count, hemoglobin,platelet count and neutrophil count) [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Assess Safety as assessed by laboratory changes in complete blood count (CBC) (including white blood cell count, hemoglobin,platelet count and neutrophil count
  • Assess Safety as assessed by laboratory changes in chemistry including electrolytes (sodium, potassium, biocarbonate, sreum creatinine) [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Assess Safety as assessed by laboratory changes in chemistry including electrolytes (sodium, potassium, biocarbonate, sreum creatinine)
  • Trop-2 expression level and relationship with efficacy outcome overall response rate [ Time Frame: At end of treatment, and average of 6 months and 30 days following last dose up to 24 months ]
    Assess baseline Trop-2 expression and correlate to Overall response rate (ORR)
  • Trop-2 expression level and relationship with efficacy outcome Progression free survival [ Time Frame: At end of treatment, and average of 6 months and 30 days following last dose up to 24 months ]
    Assess baseline Trop-2 expression and correlate to Progression Free Survival (PFS)
  • Trop-2 expression level and relationship with efficacy outcome overall survival [ Time Frame: At end of treatment, and average of 6 months and 30 days following last dose up to 24 months ]
    Assess baseline Trop-2 expression and correlate to overall survival
  • Assess Serum PK parameter Plasma Concentration (Cmax) [ Time Frame: through treatment completion, an average of 6 months ]
    Assess Serum PK parameter Plasma Concentration (Cmax)
  • Assess Serum PK parameter Area Under the Curve (AUC) [ Time Frame: through treatment completion, an average of 6 months ]
    Assess Serum PK parameters including AUC,
  • Assess Serum PK parameter Time to reach maximum concentration (Tmax) [ Time Frame: through treatment completion, an average of 6 months ]
    Assess Serum PK parameter Tmax
  • Assess Anti-drug Antibody (ADA) Concentration [ Time Frame: through treatment completion, an average of 6 months ]
    Assess ADA Concentration
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: May 24, 2019)
  • Assess DNA repair genes BRCA2 and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including BRCA2 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes BRCA2 and correlate to overall survival [ Time Frame: at baseline ]
    analyze DNA repair genes including BRCA2 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes BRCA2 and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including BRCA2 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes BRCA1 and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including to BRCA1 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes BRCA1 and correlate to overall survival rate [ Time Frame: at baseline ]
    analyze DNA repair genes including BRCA1 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes BRCA1 and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including BRCA1 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes RAD51 and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including Rad51 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATK1 and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK1 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATK2 and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK2 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATK3 and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK3 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATM and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATM at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes RAD51 and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including RAD51 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATM and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including ATM at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATK1 and correlate to overall survival rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK1 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATK2 and correlate to overall survival rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK2 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATK3 and correlate to overall survival rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK3 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes RAD51 and correlate to overall survival rate [ Time Frame: at baseline ]
    analyze DNA repair genes including RAD51 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATM and correlate to overall survival rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATM at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATK2 and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK2 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATK1 and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK1 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATK3 and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK3 at baseline and correlate with efficacy outcomes
 
Descriptive Information
Brief Title  ICMJE A Study of Sacituzumab Govitecan in Metastatic Solid Tumors (TROPICS-03)
Official Title  ICMJE A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors
Brief Summary A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU0132) in Subjects With Metastatic Solid Tumors
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Non-Small Cell Lung Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Endometrial Cancer
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Biological: IMMU-132
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: January 29, 2020)
160
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2019)
600
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03964727
Other Study ID Numbers  ICMJE Immu-132-11
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Immunomedics, Inc.
Study Sponsor  ICMJE Immunomedics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Cabilia Pichardo, MD Immunomedics, Inc.
PRS Account Immunomedics, Inc.
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP