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
  • Head and Neck Squamous Cell Carcinoma
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
  • Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

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
  • Hepatocellular Carcinoma
  • Small Cell Lung 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, >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), SCLC or HNSCC 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 except for subjects in the HCC cohort who may be enrolled if
             they meet Child Pugh B criteria (see Appendix 2).

          -  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 Tumor Response Rates as assessed by RECIST 1.1 by Investigator Assessment
Time Frame:through study completion, an average of 6 months
Safety Issue:
Description: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

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 12 cycles (approximately 9 months) and then every 9 weeks until disease progression, study completion or up to approximately 2 years
Safety Issue:
Description:Overall Response Rate (ORR) , according to RECIST 1.1 by BICR assement
Measure:Assess Serum PK parameter Plasma Concentration (Cmax)
Time Frame:through treatment completion, an average of 6 months
Safety Issue:
Description:Assess Serum PK parameter Plasma Concentration (Cmax)
Measure:Assess Serum PK parameter Area Under the Curve (AUC)
Time Frame:through treatment completion, an average of 6 months
Safety Issue:
Description:Assess Serum PK parameters including AUC,
Measure:Assess Serum PK parameter Time to reach maximum concentration (Tmax)
Time Frame:through treatment completion, an average of 6 months
Safety Issue:
Description:Assess Serum PK parameter Tmax

Details

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

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