Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors
NCT ID: NCT05024214
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
170 participants
INTERVENTIONAL
2021-11-15
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase Ib arm
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
Lenvatinib + Envafolimab
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.
Phase II cohort1-NSCLC
Subjects with non-small cell lung cancer, resistant after previous treatment with PD-(L)1 inhibitors
Lenvatinib + Envafolimab
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.
II Phase cohort1-RCC
Subjects with renal cell carcinoma, resistant after previous treatment with PD-(L)1 inhibitors
Lenvatinib + Envafolimab
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.
Phase II cohort1-HCC
Subjects with hepatocellular carcinoma, resistant after previous treatment with PD-(L)1 inhibitors
Lenvatinib + Envafolimab
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.
Phase II cohor2-experiment group
Subjects with renal cell carcinoma, no previous systemic treatment for advanced disease
Lenvatinib + Envafolimab
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.
Phase II cohort2-control group
Subjects with renal cell carcinoma, no previous systemic treatment for advanced disease
Sunitinib
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.
Interventions
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Lenvatinib + Envafolimab
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.
Sunitinib
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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3D Medicines (Sichuan) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Tianshu Liu
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The Seventh Medical Center of the PLA General Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Zhongshan Hospital,Fudan University(Xiamen Branch)
Xiamen, Fujian, China
Dongguan People's Hospital
Dongguan, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong, China
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Second Affiliater Hospital of Nanchang University
Nanchang, Jiangxi, China
THE First Hospital of Jilin University
Changchun, Jilin, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
The 960th Hospital of the PLA Joint Logistics Support Force
Jinan, Shandong, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The Cancer Affiliated Hospital of Xinjiang Medical College
Ürümqi, Xinjiang, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Fudan University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Tianshu Liu
Role: primary
Other Identifiers
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KN035-CN-010
Identifier Type: -
Identifier Source: org_study_id
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