Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, multi-center, multi-corhort Phase II study of Envafolimab alone or with Lenvatinib in patients with advanced endometrial cancer.The primary objective is to evaluate objective response rate of envafolimab alone or with lenvatinib.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Envafolimab + Lenvatinib | Experimental | Subjects receive lenvatinib daily and envafolimab once on Day 1 and 15 of the first cycle and at the beginning of each subsequent 4 week treatment cycle D1. |
|
| Envafolimab | Experimental | Subjects receive envafolimab once on Day 1 and 15 of the first cycle and at the beginning of each subsequent 4 week treatment cycle D1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Envafolimab+Lenvatinib | Drug | Envafolimab: 400mg envafolimab was administered once in D1 and D15 of the first treatment cycle and once in D1 of each subsequent 28 day cycle. Lenvatinib: the recommended Phase 2 dose (RP2D) orally 20mg QD during each 28-day cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR of Envafolimab alone or with Lenvatinib | The ORR (either confirmed complete response [CR] or partial response [PR]) based on RECIST 1.1 will be determined in participants who have measurable disease at study entry. | Up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| The duration of response (DoR) | Up to approximately 24 months | |
| Disease control rate (DCR) | Up to approximately 24 months | |
| Time to response (TTR) |
Not provided
Inclusion Criteria:
Volunteer to participate and sign the informed consent form.
Has a histologically confirmed diagnosis of endometrial carcinoma (EC). Has Documented evidence of advanced, recurrent or metastatic EC and are not candidates for curative surgery or radiation.
Failure or intolerance of standard first-line platinum-based chemotherapy regimen for EC.
Note: If recurrence occurs during adjuvant/neoadjuvant therapy or within 12 months after completion, adjuvant/neoadjuvant therapy is considered to be the first-line treatment for advanced disease. There is no restriction regarding prior hormonal therapy.
Has at least 1 measurable target lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and confirmed by Blind Independent Imaging Review Committee (BIRC).
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy of 12 weeks or more.
Sufficient organ and bone marrow function (no hematopoietic growth factor, blood transfusion or platelet therapy was given within 14 days before the first study drug treatment).
Archival tumor tissue or a newly obtained biopsy must be available prior to the first dose of study drug for biomarker analysis. Tissue samples need to be from lesions that have not received local radiotherapy.
Females of childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of study drug.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| bin She | Contact | 15973143911 | bin.she@3d-medicines.com |
| Name | Affiliation | Role |
|---|---|---|
| xiaohua Wu, Dr | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is an open-label, two-arm study, without randomization and blinding
Not provided
Not provided
Not provided
Not provided
| Envafolimab | Drug | Envafolimab: 400mg envafolimab was administered once in D1 and D15 of the first treatment cycle and once in D1 of each subsequent 28 day cycle. |
|
| Up to approximately 24 months |
| Progression-free survival (PFS) | Up to approximately 24 months |
| To evaluate the overall survival (OS) in in subjects with advance endometrial cancer | Up to approximately 24 months |
| Chongqing University Three Gorges Hospital | Recruiting | Chongqing | Chongqing Municipality | 40030 | China |
|
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
|
| Sun Yat-Sen Memorial Hospital | Recruiting | Guangzhou | Guangdong | 510120 | China |
|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
|
| Wuhan Union Hospital of China | Recruiting | Wuhan | Hubei | 430022 | China |
|
| :Hubei Cancer Hospital | Recruiting | Wuhan | Hubei | 430079 | China |
|
| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 200001 | China |
|
| Yueyang Center Hospital | Recruiting | Yueyang | Hunan | 414604 | China |
|
| :Nanjing Maternity and Child Health Care Hospital | Recruiting | Nanjing | Jiangsu | 210004 | China |
|
| Ganzhou Cancer Hospital | Recruiting | Ganzhou | Jiangxi | 341005 | China |
|
| Liaoning Cancer Hospital | Recruiting | Shenyang | Liaoning | 110801 | China |
|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250063 | China |
|
| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
|
| :Linyi Cancer Hospital | Recruiting | Linyi | Shandong | 276002 | China |
|
| Tai'an Center Hospital | Recruiting | Tai’an | Shandong | 271099 | China |
|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| Tianjin Medical University Cancer Institute&Hospital | Recruiting | Tianjing | Tianjing | 300181 | China |
|
| Cancer Hospital of The University of Chinese Academy of Sciences | Recruiting | Hangzhou | Zhejiang | 310005 | China |
|
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718749 | envafolimab |
Not provided
Not provided
Not provided