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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20210912 | Registry Identifier | China: Drug Clinical Trial Registration and Information Disclosure Platform |
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The goal of this study is to see how effective the study drug, sacituzumab govitecan-hziy, is in participants with solid tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Esophageal Squamous Cell Carcinoma (ESCC) | Experimental | Participants will receive Sacituzumab Govitecan-hziy (SG) 8 or 10 mg/kg on Days 1 and 8 of a 21-day cycle. Participants will continue treatment until disease progression or intolerable toxicity or consent withdrawal for any reason. |
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| Cohort B: Gastric or Gastroesophageal Junction Adenocarcinoma (G/GEJC) | Experimental | Participants will receive SG 8 or 10 mg/kg on Days 1 and 8 of a 21-day cycle. Participants will continue treatment until disease progression or intolerable toxicity or consent withdrawal for any reason. |
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| Cohort C: Cervical Cancer (CC) | Experimental | Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle. Participants will continue treatment until disease progression or intolerable toxicity or consent withdrawal for any reason. |
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| Cohort D: Biliary Tract Cancer (BTC) | Experimental | Participants will receive SG 8 or 10 mg/kg on Days 1 and 8 of a 21-day cycle. Participants will continue treatment until disease progression or intolerable toxicity or consent withdrawal for any reason. |
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| Cohort E: Lung Adenocarcinoma (LAC) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacituzumab Govitecan-hziy | Drug | Administered intravenously |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1) By Investigator Assessment | ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR). | Up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive progressive disease (PD) or death from any cause (whichever comes first). | Up to 4 years |
| Disease Control Rate (DCR) |
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Key Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Histologically or cytologically-documented, incurable locally advanced or metastatic solid tumor of one of the following types:
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with RECIST v 1.1, bone-only disease is not measurable and is not permitted.
Availability of archival tumor tissue or newly acquired biopsy (unstaining tumor slides, recommended from metastasis sites).
Adequate bone marrow, hepatic and renal function.
Recovered from all prior treatment-related toxicities to Grade 1 or less by NCI-CTCAE v 5.0 (except alopecia or peripheral neuropathy that may be Grade 2 or less).
Individuals must have completed all prior cancer treatments at least 2 weeks prior to the first dose including chemotherapy , radiotherapy and major surgery. Prior antibody treatment for cancer must have been completed at least 3 weeks prior to the first dose.
Individuals must have at least a 3-month life expectancy.
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Obstetrics and Gynecology Hospital, Capital Medical University | Beijing | 100006 | China | |||
| Chinese Academy of Medical Sciences Cancer Hospital |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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| ID | Term |
|---|---|
| C000608132 | sacituzumab govitecan |
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| Experimental |
Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle. Participants will continue treatment until disease progression or intolerable toxicity or consent withdrawal for any reason. |
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DCR is defined as the proportion of participants who achieve CR, PR, or stable disease (SD). |
| Up to 4 years |
| Progression-free Survival (PFS) | PFS is defined as the time from the first dose of sacituzumab govitecan-hziy (SG) until the date of objective PD, or death (whichever comes first). | Up to 4 years |
| Overall Survival (OS) | OS is defined as the time from the first dose of SG until death due to any cause. | Up to 4 years |
| Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | First dose date up to 4 years plus 30 days |
| Percentage of Participants Experiencing Serious Adverse Events (SAEs) According to NCI CTCAE Version 5.0 | First dose date up to 4 years plus 30 days |
| Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab Govitecan-hziy and Free SN-38 | Cmax is defined as the maximum observed concentration of drug. | Up to 4 years |
| PK Parameter: Tmax of Sacituzumab Govitecan-hziy and Free SN-38 | Tmax is defined as the time (observed time point) of Cmax. | Up to 4 years |
| PK Parameter: Ctrough of Sacituzumab Govitecan-hziy and Free SN-38 | Ctrough is defined as the concentration of drug at the end of the dosing interval. | Up to 4 years |
| Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs) Against SG | Up to 4 years |
| Beijing |
| 100021 |
| China |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| The First Hospital of Jilin University | Changchun | 130021 | China |
| Fujian Cancer Hospital | Fuzhou | 350014 | China |
| The Sixth Affiliated Hospital, Sun Yat-Sen University | Guangzhou | 510655 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | 310003 | China |
| Zhejiang Cancer Hospital | Hangzhou | 310022 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150076 | China |
| Anhui Provincial Hospital | Hefei | 230001 | China |
| Jiangsu Province Hospital | Nanjing | 210029 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | 43006 | China |
| Henan Cancer Hospital | Zhengzhou | 450000 | China |