Study of Sacituzumab Govitecan-hziy in Metastatic Solid Tumors
A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors
The primary objective of this study is to assess the objective response rate (ORR) of sacituzumab govitecan-hziy in adult participants with metastatic solid tumors.
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment
Objective Response Rate (ORR) According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment
Metastatic Solid Tumor
Study Arms / Comparison Groups
Description: Participants with non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), endometrial cancer, or metastatic small cell lung cancer (mSCLC) 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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
October 15, 2019
Primary Completion Date
Key Inclusion Criteria: - Individuals with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors - NSCLC (adenocarcinoma or SCC) that has progressed after prior platinum-based chemotherapy and programmed death-(ligand) 1 (PD-(L)1) directed therapy - HNSCC that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed - Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed. - Extensive stage SCLC that has progressed after prior platinum-based chemotherapy and PD-(L)1 directed therapy. No more than one prior line of systemic treatment is allowed (re-challenge with the same initial regimen is not allowed) - 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 and renal function (CrCl ≥30mL/min) - 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 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 - Additional cohort specific exclusion criteria Note: Other protocol defined Inclusion/Exclusion criteria may apply.
18 Years - N/A
Accepts Healthy Volunteers
Gilead Study Director, 1-833-445-3230 (GILEAD-0), [email protected]
Gilead Study Director, Study Director, Gilead Sciences