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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Phase II cohort1-NSCLC | Experimental | Subjects with non-small cell lung cancer, resistant after previous treatment with PD-(L)1 inhibitors |
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| II Phase cohort1-RCC | Experimental | Subjects with renal cell carcinoma, resistant after previous treatment with PD-(L)1 inhibitors |
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| Phase II cohort1-HCC | Experimental | Subjects with hepatocellular carcinoma, resistant after previous treatment with PD-(L)1 inhibitors |
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| Phase II cohor2-experiment group | Experimental | Subjects with renal cell carcinoma, no previous systemic treatment for advanced disease |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib + Envafolimab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| RP2D(Phase Ib) | Recommendation phase II dose | first Cycle (28 Days) |
| Dose Limiting Toxicity (DLT) (Phase Ib) | Number of participants who experience DLT of the first Cycle(28days) | 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. | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Two years |
| Duration of response (DoR) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | 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 | Two years |
| Time to Response(TTR) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| siying xu | Contact | +86(10) 64882533 | siying.xu@3d-medicines.com |
| Name | Affiliation | Role |
|---|---|---|
| Tianshu Liu | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Recruiting | Bengbu | Anhui | 233004 | China |
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| Phase II cohort2-control group | Experimental | Subjects with renal cell carcinoma, no previous systemic treatment for advanced disease |
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| Sunitinib | Drug | 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. |
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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. |
| 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. | Two years |
| Overall Survival (OS) | Defined as the time from experiment drug administration to death due to any cause | Two years |
Defined as the time from experiment drug administration to the first date of response was objectively documented |
| Two years |
| The Seventh Medical Center of the PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100700 | China |
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| Beijing Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100730 | China |
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| Fujian Medical University Union Hospital | Not yet recruiting | Fuzhou | Fujian | 350001 | China |
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| Zhongshan Hospital,Fudan University(Xiamen Branch) | Not yet recruiting | Xiamen | Fujian | 361015 | China |
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| Dongguan People's Hospital | Recruiting | Dongguan | Guangdong | 523059 | China |
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| Zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510280 | China |
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| The Fifth Affiliated Hospital Sun Yat-Sen University | Recruiting | Zhuhai | Guangdong | 519000 | China |
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| Harbin Medical University Cancer Hospital | Not yet recruiting | Haerbin | Heilongjiang | 150081 | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| The Second Affiliater Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
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| THE First Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130012 | China |
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| Jilin Cancer Hospital | Not yet recruiting | Changchun | Jilin | 130028 | China |
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| The First Affiliated Hospital of Dalian Medical University | Recruiting | Dalian | Liaoning | 116011 | China |
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| Shengjing Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110001 | China |
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| Liaoning Cancer Hospital & Institute | Recruiting | Shenyang | Liaoning | 110011 | China |
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| The 960th Hospital of the PLA Joint Logistics Support Force | Recruiting | Jinan | Shandong | 250031 | China |
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| First Hospital of Shanxi Medical University | Recruiting | Taiyuan | Shanxi | 030001 | China |
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| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| The Cancer Affiliated Hospital of Xinjiang Medical College | Recruiting | Ürümqi | Xinjiang | 830011 | China |
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| Yunnan Cancer Hospital | Recruiting | Kunming | Yunnan | 650118 | China |
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| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310020 | China |
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| Fudan University | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002292 | Carcinoma, Renal Cell |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
| C000718749 | envafolimab |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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