Brief Title
Study of Sacituzumab Govitecan-hziy in Metastatic Solid Tumors
Official Title
A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors
Brief Summary
The primary objective of this study is to to assess the objective response rate (ORR) of
sacituzumab govitecan-hziy in adult participants with metastatic solid tumors.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment
Secondary Outcome
Overall Response Rate (ORR) According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment
Condition
Metastatic Solid Tumor
Intervention
Sacituzumab Govitecan-hziy
Study Arms / Comparison Groups
Sacituzumab Govitecan-hziy
Description: Participants with non-small cell lung cancer (NSCLC), head and neck squameous cell carcinoma (HNSCC), or endometrial cancer will receive sacituzumab govitecan-hziy 10 mg/kg intravenously 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
Drug
Estimated Enrollment
200
Start Date
October 15, 2019
Completion Date
December 2022
Primary Completion Date
December 2022
Eligibility Criteria
Key Inclusion Criteria:
- Able to understand and give written informed consent.
- Individuals with the following histologically documented metastatic (M1, Stage IV) or
locally advanced solid tumors. 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 individual 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.
- Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma
(SCC)), that has progressed after prior platinum-based chemotherapy and
Programmed death-ligand 1 (PD-L1) or Programmed cell death protein 1 (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.
- 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 refractory to platinum based chemotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1
- Adequate hematologic counts without transfusional or growth factor support within 2
weeks of study drug initiation
- Adequate hepatic function
- Individual 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. Tumor
lesions situated in a previously irradiated area may be utilized if they are
considered measurable and progression has been demonstrated in such lesions.
Key Exclusion Criteria:
- Have had 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. Individuals 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 individuals with carcinomatous meningitis are excluded regardless of
clinical stability
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Gilead Study Director, 1-833-445-3230 (GILEAD-0), [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
Gilead Sciences
Study Sponsor
Gilead Study Director, Study Director, Gilead Sciences
Verification Date
October 2021