Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors

Details

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.

Keywords

Metastatic Non-Small Cell Lung Carcinoma Head and Neck Squamous Cell Carcinoma Endometrial Cancer Carcinoma Endometrial Neoplasms Squamous Cell Carcinoma of Head and Neck Carcinoma, Non-Small-Cell Lung IMMU-132

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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. Tumor blocks (preferably, obtained within 12 months of study entry if clinically feasible) or 20 newly sectioned slides (6 minimum) of archived biopsy/surgical specimens are requested. these specimens should be submitted within 28 days before initiating Screening, after the subject provides written informed consent. A baseline biopsy is required if archival tissue is not available. Fine needle aspirations and bone biopsies are not suitable samples.

NSCLC (adenocarcinoma or SCC), that has progressed after prior 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.

Incurable, recurrent, or metastatic HNSCC that has progressed after prior platinum based chemotherapy and PD-LI or PD-1 directed therapy Relapsed unresectable endometrial cancer that has progressed after prior platinum based chemotherapy or is refactory 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.

You CAN'T join if...

Has has 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. 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

Locations

  • University of California San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Comprehensive Cancer Centers of Nevada- Henderson accepting new patients
    Las Vegas Nevada 89052 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT03964727
Phase
Phase 2
Study Type
Interventional
Last Updated