NCT07714668招募中2 期
An Open-label , Multicenter, Multicohort, Phase II Clinical Study Evaluating the Efficacy and Safety of SYS6041 Combination Therapy for Recurrent Ovarian Cancer
CSPC Megalith Biopharmaceutical Co.,Ltd.1 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2026年8月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- The incidence of dose-limiting toxicity (DLT)
研究概览
简要总结
This is an open-label, multicenter Phase II clinical study conducted in subjects with recurrent ovarian cancer.
详细描述
The study aims to evaluate the safety/tolerability, pharmacokinetics, and preliminary efficacy of SYS6041 in combination with other agents in subjects with recurrent ovarian cancer.
Eligible subjects will receive SYS6041 in combination with different agents (carboplatin, paclitaxel, bevacizumab, enlonstobart) . Each treatment cycle lasting 3 weeks, until disease progression, intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully understand this clinical trial and voluntarily sign the written informed consent form
- •Age ≥ 18 years old
- •Histologically or cytologically confirmed high-grade serous ovarian, epithelial fallopian tube carcinoma, and primary peritoneal cancer
- •Cohort A and B：subjects with platinum-sensitive disease who have received ≤2 prior lines of systemic chemotherapy and if have a BRCAm or HRD-positive status must have recieved PARP inhibitor maintenance therapy; Cohort C: subjects with platinum-resistant disease who have received ≤3 prior lines of systemic chemotherapy
- •Disease progression or intolerability with the most recent systemic anti-tumor treatment
- •Adequate organ function with laboratory tests meeting criteria
- •Have measurable disease per RECIST v1.1
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Expected survival ≥ 3 months
- •Subjects of reproductive potential (males and females) must agree to use reliable contraceptive methods with their partner(s) throughout the trial period and for a minimum of 8 months following the last study drug administration
排除标准
- •Prior treatment with any topoisomerase I inhibitor-loaded ADC therapy
- •History of other malignancies within 3 years before randomization/first dose or concurrent active malignancies (except cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., which are allowed to enroll)
- •Subjects with active central nervous system (CNS) manifestations during the screening period, CNS metastases requiring corticosteroid therapy within 28 days prior to the first study drug administration, lesions involving the brainstem, or carcinomatous meningitis.
- •Adverse reactions from prior anti-tumor therapy have not recovered to CTCAE 6.0 grade ≤ 1 (except for toxicities such as alopecia that researchers judge to have no safety risk)
- •Major surgery within 28 days before randomization/first dose, or planned to undergo systemic or local tumor resection during the study period
- •Subjects who have received strong CYP3A4 inhibitors or strong CYP3A4 inducers within 14 days prior to randomization/first study drug administration, or who require continuous systemic administration of such agents during the study treatment period
- •History of severe gastrointestinal disease
- •History of severe cardiovascular disease
- •Uncontrolled serous effusions (e.g., pleural effusion, ascites, pericardial effusion) that necessitate frequent drainage or medical intervention within 14 days before randomization/first dose, or requirement for further intervention within 2 weeks after a previous intervention
- •Subjects with a history of interstitial lung disease (ILD) or non-infectious pneumonia, current non-infectious pneumonia requiring corticosteroid treatment, or suspected ILD/non-infectious pneumonia identified at screening
- •Active bacterial, fungal or viral infection within 14 days before randomization/first dose (defined as requiring intravenous anti-bacterial, anti-fungal or anti-viral drug therapy)
- •Active hepatitis B or hepatitis C, defined as HBsAg positive and HBV DNA > 2000 IU/mL for active hepatitis B; defined as HCV-Ab positive and HCV RNA > ULN for active hepatitis C
- •History of immunodeficiency or positive HIV antibody test during screening
- •Presence of other conditions that may interfere with participants' participation in study procedures, not in line with participants' maximum benefit from participating in the study, or affect study results: such as history of mental illness, drug abuse or substance abuse, any other clinically significant disease or condition, etc.
研究组 & 干预措施
SYS6041, enlonstobart, bevacizumab
Experimental
干预措施: SYS6041, enlonstobart, bevacizumab (Drug)
SYS6041, bevacizumab
Experimental
干预措施: SYS6041, bevacizumab (Drug)
SYS6041, carboplatin, bevacizumab
Experimental
干预措施: SYS6041, carboplatin, bevacizumab (Drug)
paclitaxel, carboplatin, bevacizumab
Active Comparator
干预措施: paclitaxel, carboplatin, bevacizumab (Drug)
结局指标
主要结局
The incidence of dose-limiting toxicity (DLT)
时间窗: At the end of Cycle 1 (each cycle is 21 days)
AEs and SAEs
时间窗: Baseline up to 30 days post last dose
Frequency and severity of AEs and SAEs (according to NCI-CTCAE 6.0);
Recommended Phase 2 Dose (RP2D )
时间窗: Up to approximately 3 years
Objective Response Rate (ORR)
时间窗: Up to approximately 3 years
次要结局
- Progression-Free-Survival (PFS)(Up to approximately 3 years)
- Overall survival (OS)(Up to approximately 3 years)
- Expression level of tumor markers(Up to approximately 3 years)
- Maximum Plasma Concentration( Cmax)(Up to approximately 3 years)
- Time to Maximum Plasma Concentration (Tmax)(Up to approximately 3 years)
- Area Under the Serum Concentration Time Curve ( AUC)(Up to approximately 3 years)
- Elimination half-life (t1/2)(Up to approximately 3 years)
- Anti-Drug Antibody（ADA）(Up to approximately 3 years)
- Disease control rate (DCR)(Up to approximately 3 years)
- Duration of Response (DoR)(Up to approximately 3 years)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
A clinical study to evaluate the effect of siddha medicine Bojana Kudori Mathirai in patients with Soothaga Vaayu (Polycystic Ovarian Disease)CTRI/2026/03/105113Dr V MAHALAKSHMI SWAATHY43
招募中
Unknown
A Prospective study to evaluate the Clinical Performance of OvaNews (Ovulation Detection Kit) for Identification of the Urinary LH Surge in Regularly Menstruating Women of Reproductive AgeCTRI/2026/01/102089Mankind Pharma Limited30
招募中
1 期
A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Early-stage and Advanced HR+ Breast CancerAdvanced Breast CancerEarly Breast CancerNCT07310420TerSera Therapeutics LLC176
招募中
2 期
Investigating Ovulation Inhibition for Use as a ContraceptiveNCT07365904Mylan Pharmaceuticals Inc60
尚未招募
不适用
Clinical Study on the Preservation of Ovarian Function Following Autologous Hematopoietic Stem Cell Transplantation Using GoserelinOvarian InsufficiencyAutologous Hematopoietic Stem Cell TransplantationNCT07552493Union Hospital, Tongji Medical College, Huazhong University of Science and Technology64