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Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors

Primary Purpose

Solid Tumors, Non-small Cell Lung Cancer, Renal Cell Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Lenvatinib + Envafolimab
Sunitinib
Sponsored by
3D Medicines (Sichuan) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Eighteen years and older;
  2. phase Ib:Histological or cytological diagnosis of Locally advanced or metastatic solid tumors (excluding hepatocellular carcinoma and thyroid carcinoma) that have progressed after standard treatment or are intolerant or have no effective treatment;
  3. phase II cohort 1:Histological or cytological diagnosis of NSCLC,RCC, HCC, resistance to previous treatment with PD-(L)1 inhibitor; previous system treatment lines≤2;
  4. phase II cohort 2:Unresectable locally advanced or metastatic or recurrent RCC;
  5. Tumor tissue samples or biopsies from FFPE archived or fresh biopsies with locally advanced/metastatic disease must be provided, and if biopsies are not available, samples obtained prior to receiving adjuvant/neoadjuvant chemotherapy are allowed;
  6. phase Ib and phase II cohort 1: Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1; Phase II cohort 2: Karnofsky physical status (KPS) assessment ≥70;
  7. Life expectancy of at least 12 weeks;
  8. At least one measurable lesion per RECIST 1.1;
  9. Adequate organ function;
  10. Signed informed consent.

Exclusion Criteria:

  1. Prior anticancer treatment within 4 weeks prior to the first dose of study drugs;
  2. Toxicity from prior anticancer therapy prior to the first dose of study drugs not recovered to ≤ grade1;
  3. Hypertension did not satisfactory controlled after antihypertensive medication
  4. Phase Ib/II: Subjects who were previously treated with Lenvatinib or who participated in a clinical trial of a generic version of Lenvatinib
  5. Phase II cohort 1, intolerance to treatment with A PD-(L)1 inhibitor; History of severe digestive disease that can affect the oral absorption of Lenvatinib/Sunitinib;
  6. Uncontrollable or significant cardiovascular or cerebrovascular disease;
  7. Active, known history or suspected autoimmune disease;
  8. Have used or require treatment with >10 mg/day of prednisone or an equivalent dose of systemic corticosteroids within 14 days prior to the first dose of study drugs;
  9. have received live attenuated vaccine within 28 days prior to the first study drug treatment or are scheduled to receive it during the study period;
  10. Subjects with known or suspected interstitial pneumonia;
  11. Any serious active infection requiring systemic antibacterial, antifungal or antiviral therapy at screening, including active tuberculosis; Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
  12. Active hepatitis B or hepatitis C;
  13. Known history of severe gastrointestinal bleeding or active hemoptysis or other severe bleeding within 6 months prior to first study drug therapy;
  14. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage ;
  15. Known active or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis;
  16. Have other primary malignancies within 5 years;
  17. Known history of contraindications or hypersensitivity reactions to any investigational drug component or any known excipients
  18. Women who are pregnant or breastfeeding.
  19. Radiographic evidence of major blood vessel invasion/infiltration may be considered for enrollment if the investigator assesses that the risk is manageable.

Sites / Locations

  • The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
  • The Seventh Medical Center of the PLA General HospitalRecruiting
  • Beijing Hospital
  • Fujian Medical University Union Hospital
  • Zhongshan Hospital,Fudan University(Xiamen Branch)
  • Dongguan People's HospitalRecruiting
  • Zhujiang Hospital of Southern Medical UniversityRecruiting
  • The Fifth Affiliated Hospital Sun Yat-Sen UniversityRecruiting
  • Harbin Medical University Cancer Hospital
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • The Second Affiliater Hospital of Nanchang University
  • THE First Hospital of Jilin University
  • Jilin Cancer Hospital
  • The First Affiliated Hospital of Dalian Medical UniversityRecruiting
  • Shengjing Hospital of China Medical UniversityRecruiting
  • Liaoning Cancer Hospital & InstituteRecruiting
  • The 960th Hospital of the PLA Joint Logistics Support ForceRecruiting
  • First Hospital of Shanxi Medical UniversityRecruiting
  • Tianjin Medical University Cancer Institute & HospitalRecruiting
  • The Cancer Affiliated Hospital of Xinjiang Medical CollegeRecruiting
  • Yunnan Cancer HospitalRecruiting
  • Sir Run Run Shaw Hospital Zhejiang University School of MedicineRecruiting
  • Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase Ib arm

Phase II cohort1-NSCLC

II Phase cohort1-RCC

Phase II cohort1-HCC

Phase II cohor2-experiment group

Phase II cohort2-control group

Arm Description

Subjects with advanced or metastatic solid tumor (excluding hepatocellular carcinoma and thyroid cancer) with disease progression or intolerance or no effective treatment after standard therapy

Subjects with non-small cell lung cancer, resistant after previous treatment with PD-(L)1 inhibitors

Subjects with renal cell carcinoma, resistant after previous treatment with PD-(L)1 inhibitors

Subjects with hepatocellular carcinoma, resistant after previous treatment with PD-(L)1 inhibitors

Subjects with renal cell carcinoma, no previous systemic treatment for advanced disease

Subjects with renal cell carcinoma, no previous systemic treatment for advanced disease

Outcomes

Primary Outcome Measures

RP2D(Phase Ib)
Recommendation phase II dose
Dose Limiting Toxicity (DLT) (Phase Ib)
Number of participants who experience DLT of the first Cycle(28days)
objective response rate (ORR) (Phase II)
Defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on investigator evaluation.

Secondary Outcome Measures

Objective response rate (ORR) (Phase Ib)
Defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on investigator evaluation.
Duration of response (DoR)
Defined as the time from response to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on investigator evaluation.
Progression Free Survival (PFS)
Defined as the time from experiment drug administration to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on investigato evaluation.
Overall Survival (OS)
Defined as the time from experiment drug administration to death due to any cause

Full Information

First Posted
August 15, 2021
Last Updated
April 9, 2023
Sponsor
3D Medicines (Sichuan) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05024214
Brief Title
Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors
Official Title
Envafolimab(KN035) in Combination With Lenvatinib in the Treatment of Advanced Solid Tumors: a Multicenter, Open-label, Phase Ib/II Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3D Medicines (Sichuan) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open-label, multi-center study of Phase Ib/II study to assess the efficacy and safety of Envafolimab combinded with Lenvatinib in the treatment of subjects with advanced solid tumors. The primary hypothesis of this study is that subjects will have a better objective response rate (ORR) when treated with Envafolimab plus Lenvatinib than SOC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors, Non-small Cell Lung Cancer, Renal Cell Carcinoma, Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase Ib arm
Arm Type
Experimental
Arm Description
Subjects with advanced or metastatic solid tumor (excluding hepatocellular carcinoma and thyroid cancer) with disease progression or intolerance or no effective treatment after standard therapy
Arm Title
Phase II cohort1-NSCLC
Arm Type
Experimental
Arm Description
Subjects with non-small cell lung cancer, resistant after previous treatment with PD-(L)1 inhibitors
Arm Title
II Phase cohort1-RCC
Arm Type
Experimental
Arm Description
Subjects with renal cell carcinoma, resistant after previous treatment with PD-(L)1 inhibitors
Arm Title
Phase II cohort1-HCC
Arm Type
Experimental
Arm Description
Subjects with hepatocellular carcinoma, resistant after previous treatment with PD-(L)1 inhibitors
Arm Title
Phase II cohor2-experiment group
Arm Type
Experimental
Arm Description
Subjects with renal cell carcinoma, no previous systemic treatment for advanced disease
Arm Title
Phase II cohort2-control group
Arm Type
Experimental
Arm Description
Subjects with renal cell carcinoma, no previous systemic treatment for advanced disease
Intervention Type
Drug
Intervention Name(s)
Lenvatinib + Envafolimab
Intervention Description
Lenvatinib will be administered with water orally once a day (with or without food) continuously in 28-day treatment cycle. Envafolimab, 400 mg per dose, subcutaneous injection, dosed on D1 and then D15 of Treatment Cycle 1, and D1 of Treatment Cycle 2 and every subsequent cycles, with every 28 days as one treatment cycle.
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Intervention Description
Sunitinib will be administered with water orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2) in 42-day treatment cycle.
Primary Outcome Measure Information:
Title
RP2D(Phase Ib)
Description
Recommendation phase II dose
Time Frame
first Cycle (28 Days)
Title
Dose Limiting Toxicity (DLT) (Phase Ib)
Description
Number of participants who experience DLT of the first Cycle(28days)
Time Frame
first Cycle (28 Days)
Title
objective response rate (ORR) (Phase II)
Description
Defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on investigator evaluation.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Objective response rate (ORR) (Phase Ib)
Description
Defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on investigator evaluation.
Time Frame
Two years
Title
Duration of response (DoR)
Description
Defined as the time from response to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on investigator evaluation.
Time Frame
Two years
Title
Progression Free Survival (PFS)
Description
Defined as the time from experiment drug administration to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on investigato evaluation.
Time Frame
Two years
Title
Overall Survival (OS)
Description
Defined as the time from experiment drug administration to death due to any cause
Time Frame
Two years
Other Pre-specified Outcome Measures:
Title
Disease control rate (DCR)
Description
Defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response or stable disease and was assessed using RECIST 1.1 based on investigato evaluation
Time Frame
Two years
Title
Time to Response(TTR)
Description
Defined as the time from experiment drug administration to the first date of response was objectively documented
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eighteen years and older; phase Ib:Histological or cytological diagnosis of Locally advanced or metastatic solid tumors (excluding hepatocellular carcinoma and thyroid carcinoma) that have progressed after standard treatment or are intolerant or have no effective treatment; phase II cohort 1:Histological or cytological diagnosis of NSCLC,RCC, HCC, resistance to previous treatment with PD-(L)1 inhibitor; previous system treatment lines≤2; phase II cohort 2:Unresectable locally advanced or metastatic or recurrent RCC; Tumor tissue samples or biopsies from FFPE archived or fresh biopsies with locally advanced/metastatic disease must be provided, and if biopsies are not available, samples obtained prior to receiving adjuvant/neoadjuvant chemotherapy are allowed; phase Ib and phase II cohort 1: Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1; Phase II cohort 2: Karnofsky physical status (KPS) assessment ≥70; Life expectancy of at least 12 weeks; At least one measurable lesion per RECIST 1.1; Adequate organ function; Signed informed consent. Exclusion Criteria: Prior anticancer treatment within 4 weeks prior to the first dose of study drugs; Toxicity from prior anticancer therapy prior to the first dose of study drugs not recovered to ≤ grade1; Hypertension did not satisfactory controlled after antihypertensive medication Phase Ib/II: Subjects who were previously treated with Lenvatinib or who participated in a clinical trial of a generic version of Lenvatinib Phase II cohort 1, intolerance to treatment with A PD-(L)1 inhibitor; History of severe digestive disease that can affect the oral absorption of Lenvatinib/Sunitinib; Uncontrollable or significant cardiovascular or cerebrovascular disease; Active, known history or suspected autoimmune disease; Have used or require treatment with >10 mg/day of prednisone or an equivalent dose of systemic corticosteroids within 14 days prior to the first dose of study drugs; have received live attenuated vaccine within 28 days prior to the first study drug treatment or are scheduled to receive it during the study period; Subjects with known or suspected interstitial pneumonia; Any serious active infection requiring systemic antibacterial, antifungal or antiviral therapy at screening, including active tuberculosis; Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) Active hepatitis B or hepatitis C; Known history of severe gastrointestinal bleeding or active hemoptysis or other severe bleeding within 6 months prior to first study drug therapy; Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage ; Known active or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis; Have other primary malignancies within 5 years; Known history of contraindications or hypersensitivity reactions to any investigational drug component or any known excipients Women who are pregnant or breastfeeding. Radiographic evidence of major blood vessel invasion/infiltration may be considered for enrollment if the investigator assesses that the risk is manageable.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
siying xu
Phone
+86(10) 64882533
Email
siying.xu@3d-medicines.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tianshu Liu
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Benbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongchen Wang
Phone
0552-3086943
Email
byyfygcp@163.com
First Name & Middle Initial & Last Name & Degree
Sheng Xue
Phone
13956348380
Email
bburo_xs@163.com
Facility Name
The Seventh Medical Center of the PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100700
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiaming Bian
Phone
010-66721842
Email
beizongjigou@163.com
First Name & Middle Initial & Last Name & Degree
Xiaosong Li
Phone
13611045728
Email
lixiaosong@Hotmail.com
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Wang
Phone
010-8513847
Email
bjyygcp@126.com
First Name & Middle Initial & Last Name & Degree
Ben Wan
Phone
13701257342
Email
wanben2000@sina.com
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiabing Zheng
Phone
0591-86218304
Email
xhyyjgb@163.com
First Name & Middle Initial & Last Name & Degree
Song Zheng
Phone
13365910265
Email
zhengwu_99@outlook.com
Facility Name
Zhongshan Hospital,Fudan University(Xiamen Branch)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361015
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiyong LU
Phone
0592-3569860
Email
ec@zsxmhospital.com
First Name & Middle Initial & Last Name & Degree
Zhiming Wang
Phone
13611905153
Email
wzming@126.com
Facility Name
Dongguan People's Hospital
City
Dongguan
State/Province
Guangdong
ZIP/Postal Code
523059
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Limin Cai
Phone
0769-28636392
Email
dgrmyy_gcp@163.com
First Name & Middle Initial & Last Name & Degree
Yun Jia
Phone
13829139286
Email
dgryjy@sina.com
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Wang
Phone
020-62783372
Email
zjyygcp@163.com
First Name & Middle Initial & Last Name & Degree
Chunxiao Liu
Phone
13302296795
Email
Liuchx888@163.com
Facility Name
The Fifth Affiliated Hospital Sun Yat-Sen University
City
Zhuhai
State/Province
Guangdong
ZIP/Postal Code
519000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pengfei Pang 0756-2528188
Phone
0756-2528188
Email
zdwygcp@126.com
First Name & Middle Initial & Last Name & Degree
Yingbo Dai
Phone
13709699517
Email
daiyingbo@126.com
Facility Name
Harbin Medical University Cancer Hospital
City
Haerbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang
Phone
0451-86298115
Email
sylcyj609@163.com
First Name & Middle Initial & Last Name & Degree
Yanqiao Zhang
Phone
138 4512 0210
Email
yanqiaozhanggcp@163.com
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanru Qin
Phone
0371-66295624
Email
ZDYFYgcp@163.com
Facility Name
The Second Affiliater Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoshu Cheng
Phone
0791-86297032
Email
efyjgb@126.com
First Name & Middle Initial & Last Name & Degree
Zimin Shi
Phone
18979116622
Email
18979116622@189.cn
Facility Name
THE First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Liu
Phone
0431-88786014
Email
wangfei5780@126.com
First Name & Middle Initial & Last Name & Degree
Wei Li
Phone
13756661267
Email
jdyylw@163.com
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130028
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yin Cheng
Phone
0431-80596065
Email
xjy0202@163.com
First Name & Middle Initial & Last Name & Degree
Yin Cheng
Phone
13943012851
Email
jl.cheng@163.com
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yinan Wang
Phone
0411-83635963-3015
Email
dyyykyb@126.com
First Name & Middle Initial & Last Name & Degree
Jiwei Liu
Phone
18098877966
Email
jiweiliudl@126.com
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Wu
Phone
18940256666
Email
wub@sj-hospital.org
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lixuan Wei
Phone
024-31916651
Email
kjkwlx@163.com
First Name & Middle Initial & Last Name & Degree
Cheng Fu
Phone
13840219900
Email
13840219900@163.com
Facility Name
The 960th Hospital of the PLA Joint Logistics Support Force
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinmin Guo
Phone
0531-51666295
Email
ylk666295@163.com
First Name & Middle Initial & Last Name & Degree
Baocheng Wang
Phone
13605310886
Email
baochengwang@hotmail.com
Facility Name
First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongguo Liu
Phone
0351-4639071
Email
lzgwyy@sina.com
First Name & Middle Initial & Last Name & Degree
Xiaoming Cao
Phone
13994205917
Email
drcxm@126.com
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meijun Liu
Phone
022-23340123-6417
Email
ec_tjcih@126.com
First Name & Middle Initial & Last Name & Degree
Xiubao Ren
Phone
18622221235
Email
xiubao_ren@126.com
Facility Name
The Cancer Affiliated Hospital of Xinjiang Medical College
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiyan Wang
Phone
0991-7819430
Email
xjzlyygcp@126.com
First Name & Middle Initial & Last Name & Degree
Peng Chen
Phone
13609982787
Email
chenpeng9@126.com
Facility Name
Yunnan Cancer Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650118
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuemei Chen
Phone
0871-68103376
Email
zhongliugcp@aliyun.com
First Name & Middle Initial & Last Name & Degree
Yong Yang
Phone
18987051431
Email
yongy1974@163.com
Facility Name
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuxiang Zhang
Phone
0571-86006992
Email
zhangshuxiang87@foxmail.con
First Name & Middle Initial & Last Name & Degree
Hongming Pan
Phone
13605716662
Email
shonco@163.com
Facility Name
Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianshu Liu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors

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