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 with elevated Trop-2
expression.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective Response Rate
Secondary Outcome
Overall Response Rate (ORR) according to RECIST 1.1 by 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
160
Start Date
August 6, 2019
Completion Date
August 2022
Primary Completion Date
April 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 (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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Cabilia Pichardo, MD, ,
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
December 2019