NCT06560112招募中2 期
An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer
Akeso1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2024年11月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by investigator
研究概览
简要总结
An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer
详细描述
This is a Phase 2, open label, multicohort, multicenter study designed to evaluate the efficacy and safety of combination therapy of AK104, AK112 and chemotherapy in recurrent ovarian cancer.
AK104 is a bispecific monoclonal antibody targeting both CTLA-4 and PD-1. AK112 is a bispecific monoclonal antibody targeting VEGF and PD-1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signs the written informed consent form.
- •Female participants who are at least 18 years of age on the day of signing informed consent with.
- •ECOG of 0 or
- •Life expectancy ≥ 3 months.
- •Histologically diagnosed high-grade epithelial ovarian cancer (including high-grade serous, clear cell, G3 endometrioid) that has relapsed after platinum-containing standard chemotherapy.
- •Recurrence of Platinum-sensitive (relapse ≥6 months after the end of platinum-containing therapy) who is not suitable for platinum-containing therapy after ≥ 3 lines of therapy;
- •Recurrence of platinum resistance , ≤3 previous lines of therapy. Note: Ovarian cancer includes ovarian cancer, fallopian tube cancer and primary peritoneal cancer in this study, unless otherwise specified.
- •Has measurable disease based on RECIST v1.1 as determined by the site study team.
- •Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue.
- •Has adequate organ function.
- •All subjects of reproductive potential must agree to use an effective method of contraception, during and for 6 months after the last dose of study treatment.
排除标准
- •Other pathological types such as mucinous cancer, low-grade serous carcinoma, carcinosarcoma, sex cord stromal cell tumor, etc.
- •Presence of central nervous system (CNS) metastases or carcinomatous meningitis.
- •Subjects with uncontrollable pleural, pericardial, or peritoneal effusion requiring repeated drainage.
- •Patients with other active malignancies within 3 years prior to randomization.
- •Received systemic anti-tumor therapy within 3 weeks prior to randomization.
- •Any prior treatments targeting the mechanism of tumor immunity.
- •Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study.
- •Active or potentially recurrent autoimmune disease.
- •Subjects who require systemic treatment with glucocorticoid (> 10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to randomization.
- •Use of live vaccines within 4 weeks prior to randomization.
- •Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies.
- •Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- •Known history of interstitial lung disease or non-infectious pneumonitis.
- •Serious infections requiring hospitalization.
- •Presence of active infection requiring systemic therapy.
- •Subjects with active hepatitis B and active viral hepatitis C.
- •Active or documented inflammatory bowel diseases, active diverticulitis.
- •Patients with clinically significant cardio-cerebrovascular disease.
- •Unresolved toxicities from prior anticancer therapy.
- •History of severe hypersensitivity reactions to other mAbs.
- •Pregnant or lactating women.
- •Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug.
- •Exclusion Criteria for Chemotherapy-Related Cohorts (Cohorts 1,2,4): Known contraindications or allergy to PLD, paclitaxel or topotecan.
- •Exclusion Criteria for AK112-Related Cohorts (Cohorts 2,3,4): Known contraindications or allergy to any component of VEGF mABs or any medical conditions that affect the safety of AK112.
研究组 & 干预措施
Cohort 1
Experimental
AK104 q3w +Chemo
干预措施: AK104 (Drug)
Cohort 1
Experimental
AK104 q3w +Chemo
干预措施: Chemotherapy (Drug)
Cohort 2
Experimental
AK112 q3w +Chemo
干预措施: AK112 (Drug)
Cohort 2
Experimental
AK112 q3w +Chemo
干预措施: Chemotherapy (Drug)
Cohort 3
Experimental
AK112 q3w +AK104 q6w
干预措施: AK104 (Drug)
Cohort 3
Experimental
AK112 q3w +AK104 q6w
干预措施: AK112 (Drug)
Cohort 4
Experimental
AK112 q3w +AK104 q6w +Chemo
干预措施: AK104 (Drug)
Cohort 4
Experimental
AK112 q3w +AK104 q6w +Chemo
干预措施: AK112 (Drug)
Cohort 4
Experimental
AK112 q3w +AK104 q6w +Chemo
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by investigator
时间窗: Up to 2 years
Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria
次要结局
- Time to Response (TTR) assessed by investigator per RECIST v1.1(Up to 2 years)
- progression-free survival (PFS) assessed by investigator per RECIST v1.1(Up to 2 years)
- Overall Survival(OS)(Up to 2 years)
- Number of participants with adverse event (AE)(Up to 2 years)
- duration of Response (DOR) assessed by investigator per RECIST v1.1(Up to 2 years)
研究者
研究点 (1)
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