A multicenter, open-label, phase 2, basket study to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab in subjects with selected solid tumors
概览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.
- 入组人数
- 101
- 试验地点
- 22
- 主要终点
- The primary study endpoints of safety are the number of subjects with dose-limiting toxicities (side effects due to the study drug), number of subjects with adverse events (any side effects related or unrelated to the study drug) and number of subjects discontinuing the study drug due to adverse events.
概览
简要总结
The main purpose of this study is to see if SKB264 in combination with pembrolizumab is safe and effective in treating selected solid tumors.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male and/or females of age 18 years and older who have histologically or cytologically confirmed locally advanced or metastatic cancer or recurrent cancer (Cervical, Urothelial, Ovarian, Prostate or Endometrial cancer).
排除标准
- •Subjects with active central nervous system tumors or metastases.
- •Subjects with hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or active Tuberculosis.
- •Subjects with a history of allogeneic tissue or solid organ transplant.
- •Subjects who received any chemotherapy, radiotherapy, immunotherapy, or biologic therapy treatment within 4 weeks before the first dose of the study drug.
研究组 & 干预措施
-
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
The primary study endpoints of safety are the number of subjects with dose-limiting toxicities (side effects due to the study drug), number of subjects with adverse events (any side effects related or unrelated to the study drug) and number of subjects discontinuing the study drug due to adverse events.
The primary study endpoints of safety are the number of subjects with dose-limiting toxicities (side effects due to the study drug), number of subjects with adverse events (any side effects related or unrelated to the study drug) and number of subjects discontinuing the study drug due to adverse events.
The primary study endpoints of efficacy are the proportion of subjects with a confirmed complete response or partial response and the percentage of subjects who have a negative change (decrease) in prostate-specific antigen level (a type of protein produced by prostate gland in men).
The primary study endpoints of efficacy are the proportion of subjects with a confirmed complete response or partial response and the percentage of subjects who have a negative change (decrease) in prostate-specific antigen level (a type of protein produced by prostate gland in men).
次要结局
- Vital signs, physical examination, laboratory tests, 12-lead electrocardiogram/ echocardiogram/multiple-gated acquisition scan (MUGA), and eastern cooperative oncology group performance status. These tests will be done to assess the safety of SKB264 in combination with pembrolizumab.
- The disease control rate, duration of response, progressionfree survival, and overall survival. These are the tests to assess the antitumor activity (preventing or inhibiting the formation or growth of tumors) of SKB264 in combination with pembrolizumab
- Area under the serum concentration curve (AUC): AUC shows how much drug has entered the blood over a period of time.
- Maximum serum concentration (Cmax): Cmax shows the most amount of drug found in blood after one dose is given.
- Minimum serum concentration (Cmin): Cmin is the least amount of drug that remains in blood after one dose is given.
- Test for presence of antibodies against the study drug. Number of subjects with positive anti-drug antibodies (ADA) test.
- ADA titers (concentration of ADA in blood)
研究者
Chief Medical Officer
Scientific
Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.