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Advanced Endometrial CancerPhase 2NCT05112991

Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer

A Phase 2 study testing Envafolimab+Lenvatinib and Envafolimab in people with Advanced Endometrial Cancer, run by 3D Medicines (Sichuan) Co., Ltd. at 19 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced Endometrial Cancer
What is being tested?
Envafolimab+Lenvatinib and Envafolimab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
19 sitesChina
Study dates
4 Mar 2022to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • Previous lab results showed dMMR or MSI-H.
  • Participate in the clinical trials of other investigational drugs within 28 days before the first medication; or have received anti-tumor treatment within 2 weeks, including but not limited to chemotherapy and radiotherapy or targeted therapy.
  • The toxicity of previous anti-tumor treatments has not recovered to 0 or 1 level.
  • Recieved major surgery with 28 days before the first medication or has serious nonhealing wound, ulcer, or bone fracture at screening.
  • Has received prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • Uncontrolled blood pressure (BP) with or without antihypertensive medications, defined as BP >150/90 mmHg.
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  • Uncontrolled or major Cardio-cerebral vascular disease.
  • Have active, or have had autoimmune diseases or risks that may recur. However, subjects required only replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) or with skin diseases that do not require systemic treatmentare are allowed to be included.
  • Subjects who need to use corticosteroids (> 10 mg/day prednisone equivalent dose) for systemic therapy within 14 days before the study drug is administered.
  • Has received a live-virus vaccination within 28 days of planned treatment start or plan to reveived a live-virus vaccination during the study.
  • Has current or suspected (non-infectious) pneumonitis.
  • Active infection (any infection requiring systemic treatment).
  • Has active Hepatitis B or C.
  • Is positive for Human Immunodeficiency Virus (HIV).
  • Has uncontrolled pericardial effusion, pleural effusion or ascites.
  • Has symptomatic/active brain metastasis or meningeal carcinomatosis; for patients with brain metastases who have previously received treatment, if the clinical and imaging evidence does not indicate disease progression within 4 weeks before the first study drug treatment, and 2 weeks before the first administration There is no need to receive corticosteroid treatment and can be considered for inclusion.
  • Suffered from other known malignant tumors within 5 years before enrollment (except for treated skin basal cell carcinoma, skin squamous cell carcinoma and/or carcinoma in situ after radical resection).
  • Hypersensitivity to either of the study drug or its components.
  • Females who are pregnant or breastfeeding and who refuse to use a highly effective method of contraception throughout the entire study period, and for 6 months after the last dose of study drug;
  • According to the judgement of the investigators, there are other factors indicate that the subject should not be enrolled.
  • Has received prior treatment with any treatment targeting VEGF-directed angiogenesis.
  • Has radiographic evidence of major blood vessel invasion/infiltration.
  • Has a history of hypertensive crisis or hypertensive encephalopathy.
  • Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.
  • Has a history of serious bleeding disease within 6 months prior to the first dose of study drug.

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

bin She contact

15973143911

bin.she@3d-medicines.com

19 sites in 1 country

China19 sites, 19 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Yunong Gao, 010-88196210, gao_fuke@126.com

    Yunong Gao

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 200001

    Chun Fu, 18627315906, fuchun0814@csu.edu.cn

    Chun Fu

    Recruiting

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 40030

    Wenhua Ran, 13896379605, 2857002479@qq.com

    Wenhua Ran

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Qin Xu, 13950419396, 1379423879@qq.com

    Qin Xu

    Recruiting

  • Ganzhou Cancer Hospital

    Ganzhou, Jiangxi, 341005

    Xiuhong Wu, 13879728933, Wxh95051@163.com

    Xiuhong Wu

    Recruiting

  • Sun Yat-Sen Memorial Hospital

    Guangzhou, Guangdong, 510120

    Bingzhong Zhang, 13925063030, zhbzhong@mail.sysu.edu.cn

    Bingzhong Zhang

    Recruiting

  • Cancer Hospital of The University of Chinese Academy of Sciences

    Hangzhou, Zhejiang, 310005

    Xiang Zhang, 15988109696, zhangxiang@zjcc.org.cn

    Xiang Zhang

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250063

    Youzhong Zhang, 18560081866, zhangyouzhong@vip.sina.com

    Youzhong Zhang

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Qingshui Li, 13854158117, liqingshui64@163.com

    Qingshui Li

    Recruiting

  • :Linyi Cancer Hospital

    Linyi, Shandong, 276002

    Xiumin Li, 13583991399, Lyzlyylxm@163.com

    Xiumin Li

    Recruiting

  • :Nanjing Maternity and Child Health Care Hospital

    Nanjing, Jiangsu, 210004

    Xuemei Jia, 15205177401, xmjia@njmu.edu.cn

    Xuemei Jia

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    xiaohua Wu, 13601772486, docwuxh@yahoo.com

    xiaohua Wu

    Recruiting

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110801

    Danbo Wang, 18940251157, danbo_wang@126.com

    Danbo Wang

    Recruiting

  • Tai'an Center Hospital

    Tai’an, Shandong, 271099

    Zhaofeng Zhu, 13375389119, zhuzf8498607@163.com

    Zhaofeng Zhu

    Recruiting

  • Tianjin Medical University Cancer Institute&Hospital

    Tianjing, Tianjing, 300181

    Ke Wang, 18622221098, 18622221098@163.com

    Ke Wang

    Recruiting

  • Wuhan Union Hospital of China

    Wuhan, Hubei, 430022

    guiling Li, 13307187507, lgl6714@163.com

    guiling Li

    Recruiting

  • :Hubei Cancer Hospital

    Wuhan, Hubei, 430079

    Yi Huang, 18971650655, huangyt32@hotmail.com

    Yi Huang

    Recruiting

  • Yueyang Center Hospital

    Yueyang, Hunan, 414604

    Jianbing Hu, 13873000328, Jianbinghu409@sohu.com

    Jianbing Hu

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Yanlin Luo, 15038373216, luoyanlin2002@126.com

    Yanlin Luo

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Multi-center, Multi-corhort Phase II Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer

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.

Being tested
Envafolimab+Lenvatinib, Envafolimab
Keywords
endometrial cancer
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Envafolimab+LenvatinibDrug

    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.

  • EnvafolimabDrug

    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.

Study groups in NCT05112991
Study groupRoleWhat they receive
Envafolimab + LenvatinibExperimentalSubjects 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.
Receives: Drug: Envafolimab+Lenvatinib
EnvafolimabExperimentalSubjects receive envafolimab once on Day 1 and 15 of the first cycle and at the beginning of each subsequent 4 week treatment cycle D1.
Receives: Drug: Envafolimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 24 months

Secondary outcomes (5)

  1. The duration of response (DoR）

    Measured: Up to approximately 24 months

  2. Disease control rate (DCR)

    Measured: Up to approximately 24 months

  3. Time to response (TTR)

    Measured: Up to approximately 24 months

  4. Progression-free survival (PFS)

    Measured: Up to approximately 24 months

  5. To evaluate the overall survival (OS) in in subjects with advance endometrial cancer

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2021
  2. Study start4 Mar 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Factorial
Model description
This study is an open-label, two-arm study, without randomization and blinding
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05112991
Sponsor's protocol ID
KN035-CN-011
Status last verified
Mar 2026
First submitted
28 Oct 2021
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Envafolimab+Lenvatinib and Envafolimab in people with Advanced Endometrial Cancer, run by 3D Medicines (Sichuan) Co., Ltd. at 19 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact bin She (15973143911, bin.she@3d-medicines.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR of Envafolimab alone or with Lenvatinib (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05112991.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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