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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
1. Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment
Secondary Outcome
2. Overall Response Rate (ORR) According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment
Condition
Metastatic Non-Small Cell Lung Carcinoma
Intervention
IMMU-132
Study Arms / Comparison Groups
IMMU-132
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
200
Start Date
August 6, 2019
Completion Date
November 2024
Primary Completion Date
May 2022
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. 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.
Exclusion Criteria:
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Cabilia Pichardo, MD, 888-983-4668, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03964727
Organization ID
Immu-132-11
Responsible Party
Sponsor
Study Sponsor
Immunomedics, Inc.
Study Sponsor
Cabilia Pichardo, MD, Study Chair, Immunomedics, Inc.
Verification Date
April 2021