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This is an open-label, single arm , Ib/II phase trial to evaluate the efficacy and safety of AK112(ivonescimab)monotherapy as first-line treatment for favourable risk advanced/metastatic renal cell carcinoma (a/m RCC).
Subjects will receive AK112 until disease progression, unacceptable toxic effects, death,a decision by the physician or patient to withdraw from the trial,or AK112 exposure over 2 years.
The study set dose exploration stage and dose expansion stage respectively. Firstly, include a few subjects for observation in dose exploration stage, and select appropriate dose to enter expansion, then continue to include more subjects to further assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Subjects will receive AK112 (RP2D, administered intravenously,Q3W) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK112 monotherapy | Drug | A novel PD-1/VEGF bispecific antibody; RP2D intravenously (IV),Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR per RECIST v1.1 assessed by investigators | ORR is the proportion of subjects with complete response(CR) and partial response(PR) , based on RECIST v1.1 | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| DCR per RECIST v1.1 as assessed by investigators | DCR is the proportion of subjects with complete response(CR), partial response(PR) and stable disease (SD) based on RECIST v1.1 | Up to 2 years |
| Duration of response (DOR) |
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Inclusion Criteria:
Note: Prior neoadjuvant/adjuvant therapies are acceptable if disease progression occurred > 6 months after last dosage of neoadjuvant/adjuvant treatment.
Exclusion Criteria:
Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or carcinoma in situ are not excluded.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinan Sheng, MD | Contact | +86-10-88196348 | doctor_sheng@126.com |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Duration of response (DOR) assessed according to RECIST v1.1
| Up to 2 years |
| Progression-free survival (PFS) | PFS is defined as the time from the the start of treatment till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first). | 3 years |
| Overall survival (OS) | OS is the time from the first use of a therapeutic drug to death from any cause | 4 years |
| Treatment-related adverse events | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, also types and degree | 3 years |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |