Solid TumorsPhase 1/2NCT05024214
Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors
A Phase 1/2 study testing Lenvatinib + Envafolimab and Sunitinib in people with Solid Tumors and Non-small Cell Lung Cancer, run by 3D Medicines (Sichuan) Co., Ltd. at 23 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Non-small Cell Lung Cancer, Renal Cell Carcinoma
- What is being tested?
- Lenvatinib + Envafolimab and Sunitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 23 sitesChina
- Study dates
- 15 Nov 2021to Dec 2026
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
Show all 10Show fewer
- Life expectancy of at least 12 weeks;
- At least one measurable lesion per RECIST 1.1;
- Adequate organ function;
- Signed informed consent.
Who cannot join
- 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;
Show all 19Show fewer
- 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.
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
China23 sites, 23 recruiting
- Recruiting
The Seventh Medical Center of the PLA General Hospital
Beijing, Beijing Municipality, 100700
Jiaming Bian, 010-66721842, beizongjigou@163.com
Xiaosong Li, 13611045728, lixiaosong@Hotmail.com
- Not yet recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100730
Xin Wang, 010-8513847, bjyygcp@126.com
Ben Wan, 13701257342, wanben2000@sina.com
- Recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
Hongchen Wang, 0552-3086943, byyfygcp@163.com
Sheng Xue, 13956348380, bburo_xs@163.com
- Not yet recruiting
THE First Hospital of Jilin University
Changchun, Jilin, 130012
Li Liu, 0431-88786014, wangfei5780@126.com
Wei Li, 13756661267, jdyylw@163.com
- Not yet recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130028
Yin Cheng, 0431-80596065, xjy0202@163.com
Yin Cheng, 13943012851, jl.cheng@163.com
- Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Yinan Wang, 0411-83635963-3015, dyyykyb@126.com
Jiwei Liu, 18098877966, jiweiliudl@126.com
- Recruiting
Dongguan People's Hospital
Dongguan, Guangdong, 523059
Limin Cai, 0769-28636392, dgrmyy_gcp@163.com
Yun Jia, 13829139286, dgryjy@sina.com
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Jiabing Zheng, 0591-86218304, xhyyjgb@163.com
Song Zheng, 13365910265, zhengwu_99@outlook.com
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
Qian Wang, 020-62783372, zjyygcp@163.com
Chunxiao Liu, 13302296795, Liuchx888@163.com
- Not yet recruiting
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, 150081
Qingyuan Zhang, 0451-86298115, sylcyj609@163.com
Yanqiao Zhang, 138 4512 0210, yanqiaozhanggcp@163.com
- Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310020
Shuxiang Zhang, 0571-86006992, zhangshuxiang87@foxmail.con
Hongming Pan, 13605716662, shonco@163.com
- Recruiting
The 960th Hospital of the PLA Joint Logistics Support Force
Jinan, Shandong, 250031
Jinmin Guo, 0531-51666295, ylk666295@163.com
Baocheng Wang, 13605310886, baochengwang@hotmail.com
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
Xuemei Chen, 0871-68103376, zhongliugcp@aliyun.com
Yong Yang, 18987051431, yongy1974@163.com
- Not yet recruiting
The Second Affiliater Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Xiaoshu Cheng, 0791-86297032, efyjgb@126.com
Zimin Shi, 18979116622, 18979116622@189.cn
- Recruiting
Fudan University
Shanghai
Tianshu Liu
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110001
Bin Wu, 18940256666, wub@sj-hospital.org
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110011
Lixuan Wei, 024-31916651, kjkwlx@163.com
Cheng Fu, 13840219900, 13840219900@163.com
- Recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Zhongguo Liu, 0351-4639071, lzgwyy@sina.com
Xiaoming Cao, 13994205917, drcxm@126.com
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Meijun Liu, 022-23340123-6417, ec_tjcih@126.com
Xiubao Ren, 18622221235, xiubao_ren@126.com
- Recruiting
The Cancer Affiliated Hospital of Xinjiang Medical College
Ürümqi, Xinjiang, 830011
Xiyan Wang, 0991-7819430, xjzlyygcp@126.com
Peng Chen, 13609982787, chenpeng9@126.com
- Not yet recruiting
Zhongshan Hospital,Fudan University(Xiamen Branch)
Xiamen, Fujian, 361015
Zhiyong LU, 0592-3569860, ec@zsxmhospital.com
Zhiming Wang, 13611905153, wzming@126.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Yanru Qin, 0371-66295624, ZDYFYgcp@163.com
- Recruiting
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong, 519000
Pengfei Pang 0756-2528188, 0756-2528188, zdwygcp@126.com
Yingbo Dai, 13709699517, daiyingbo@126.com
About this study
Official title: Envafolimab(KN035) in Combination With Lenvatinib in the Treatment of Advanced Solid Tumors: a Multicenter, Open-label, Phase Ib/II Study
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.
- Being tested
- Lenvatinib + Envafolimab, Sunitinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenvatinib + EnvafolimabDrug
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.
SunitinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib arm | Experimental | 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 Receives: Drug: Lenvatinib + Envafolimab |
| Phase II cohort1-NSCLC | Experimental | Subjects with non-small cell lung cancer, resistant after previous treatment with PD-(L)1 inhibitors Receives: Drug: Lenvatinib + Envafolimab |
| II Phase cohort1-RCC | Experimental | Subjects with renal cell carcinoma, resistant after previous treatment with PD-(L)1 inhibitors Receives: Drug: Lenvatinib + Envafolimab |
| Phase II cohort1-HCC | Experimental | Subjects with hepatocellular carcinoma, resistant after previous treatment with PD-(L)1 inhibitors Receives: Drug: Lenvatinib + Envafolimab |
| Phase II cohor2-experiment group | Experimental | Subjects with renal cell carcinoma, no previous systemic treatment for advanced disease Receives: Drug: Lenvatinib + Envafolimab |
| Phase II cohort2-control group | Experimental | Subjects with renal cell carcinoma, no previous systemic treatment for advanced disease Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
RP2D(Phase Ib)
Recommendation phase II dose
Measured: first Cycle (28 Days)
Dose Limiting Toxicity (DLT) (Phase Ib)
Number of participants who experience DLT of the first Cycle（28days)
Measured: first Cycle (28 Days)
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.
Measured: Two years
Secondary outcomes (4)
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.
Measured: Two years
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.
Measured: Two years
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.
Measured: Two years
Overall Survival (OS)
Defined as the time from experiment drug administration to death due to any cause
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start15 Nov 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 3D Medicines (Sichuan) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tianshu Liu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024214
- Sponsor's protocol ID
- KN035-CN-010
- Status last verified
- Mar 2026
- First submitted
- 15 Aug 2021
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Envafolimab(KN035) in Combination With Lenvatinib in the Treatment of Advanced Solid Tumors: a Multicenter, Open-label, Phase Ib/II Study
- ClinicalTrials.gov ID
- NCT05024214
- Acronym / sponsor ID
- KN035-CN-010
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- 3D Medicines (Sichuan) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Phase Ib arm | Experimental | Drug: Lenvatinib + EnvafolimabSubjects with advanced or metastatic solid tumor (excluding hepatocellular carcinoma and thyroid cancer) with disease progression or intolerance or no effective treatment after standard therapy |
| Phase II cohort1-NSCLC | Experimental | Drug: Lenvatinib + EnvafolimabSubjects with non-small cell lung cancer, resistant after previous treatment with PD-(L)1 inhibitors |
| II Phase cohort1-RCC | Experimental | Drug: Lenvatinib + EnvafolimabSubjects with renal cell carcinoma, resistant after previous treatment with PD-(L)1 inhibitors |
| Phase II cohort1-HCC | Experimental | Drug: Lenvatinib + EnvafolimabSubjects with hepatocellular carcinoma, resistant after previous treatment with PD-(L)1 inhibitors |
| Phase II cohor2-experiment group | Experimental | Drug: Lenvatinib + EnvafolimabSubjects with renal cell carcinoma, no previous systemic treatment for advanced disease |
| Phase II cohort2-control group | Experimental | Drug: SunitinibSubjects with renal cell carcinoma, no previous systemic treatment for advanced disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenvatinib + EnvafolimabLenvatinib 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. | Drug | II Phase cohort1-RCC, Phase II cohor2-experiment group, Phase II cohort1-HCC, Phase II cohort1-NSCLC, Phase Ib arm |
| SunitinibSunitinib 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. | Drug | Phase II cohort2-control group |
Primary outcome
RP2D(Phase Ib)
Time frame: first Cycle (28 Days)
Recommendation phase II dose
Dose Limiting Toxicity (DLT) (Phase Ib)
Time frame: first Cycle (28 Days)
Number of participants who experience DLT of the first Cycle（28days)
objective response rate (ORR) （Phase II）
Time frame: Two years
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.
4 secondary outcomes
Objective response rate (ORR) （Phase Ib）
Time frame: Two years
Duration of response (DoR)
Time frame: Two years
Progression Free Survival (PFS)
Time frame: Two years
Overall Survival (OS)
Time frame: Two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: Undecided
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tianshu Liu principal investigator
Fudan University
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lenvatinib + Envafolimab and Sunitinib in people with Solid Tumors and Non-small Cell Lung Cancer, run by 3D Medicines (Sichuan) Co., Ltd. at 23 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 19 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 23 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 siying xu (+86(10) 64882533, siying.xu@3d-medicines.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RP2D(Phase Ib) (time frame: first Cycle (28 Days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 7 Nov 2026.