Clinical Trials /

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

NCT03964727

Description:

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

Related Conditions:
  • Endometrial Carcinoma
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Suspended

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Sacituzumab Govitecan in Metastatic Solid Tumors (TROPICS-03)
  • Official Title: A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: Immu-132-11
  • NCT ID: NCT03964727

Conditions

  • Metastatic Non-Small Cell Lung Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Endometrial Cancer

Interventions

DrugSynonymsArms
IMMU-132sacituzumab govitecanIMMU-132

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
IMMU-132ExperimentalIMMU-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.
  • IMMU-132

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate
Time Frame:through study completion, an average of 6 months
Safety Issue:
Description: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

Measure: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
Safety Issue:
Description:Overall Response Rate (ORR) , according to RECIST 1.1 by BICR assement
Measure:Assess the Safety Pharmacokinetics of hRS7-IgG & hRS&-SN38
Time Frame:through treatment completion, an average of 6 months
Safety Issue:
Description: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
Measure:Assess the Plasma Concentration of hRS7-IgG & hRS&-SN38
Time Frame:through treatment completion, an average of 6 months
Safety Issue:
Description: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
Measure:Assess the Time of Peak Concentration of hRS7-IgG & hRS&-SN38
Time Frame:through treatment completion, an average of 6 months
Safety Issue:
Description: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
Measure:Assess the AUCinf of hRS7-IgG & hRS&-SN38
Time Frame:through treatment completion, an average of 6 months
Safety Issue:
Description:Area under the plasma concentration versus time curve from zero to infinity of hRS7-IgG & hRS7-SN38
Measure:Assess the CL/f of hRS7-IgG & hRS&-SN38
Time Frame:through treatment completion, an average of 6 months
Safety Issue:
Description:Clearance/Bioavailability of hRS7-IgG & hRS7-SN38
Measure:Assess the t1/2 of hRS7-IgG & hRS&-SN38
Time Frame:through treatment completion, an average of 6 months
Safety Issue:
Description:Terminal half life of hRS7-IgG & hRS7-SN38
Measure:Immunogenicity by ADA
Time Frame:through treatment completion, an average of 6 months
Safety Issue:
Description:Assess the Immunogenicity of Sacituzumab-Govitecan by Anti-Drug Assay (ADA)

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Immunomedics, Inc.

Last Updated

January 29, 2020