NCT07814066尚未招募2 期
A Multicenter, Open-label, Phase II Umbrella Study to Evaluate the Efficacy and Safety of the Investigational Product in Participants With Advanced or Metastatic Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a multicenter, open-label, Phase II umbrella study conducted in participants with advanced or metastatic pancreatic cancer. This study has set up different cohorts to evaluate the efficacy and safety of multiple investigational products in pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form.
- •Histologically or cytologically confirmed advanced or metastatic pancreatic cancer.
- •Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 7 days before the first dose.
- •Participants who have adequate bone marrow, liver, kidney, and coagulation function.
- •Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.
- •Participants must voluntarily join this study, sign the informed consent form (ICF), and be able to comply with the visits and related procedures specified in the protocol.
排除标准
- •History or current metastases to central nervous system.
- •Histologically or cytologically confirmed other pathological types or differentiation combined with other pathological types.
- •Subjects with other malignant tumors within 3 years prior to the first dose.
- •Presence of any cardiovascular and cerebrovascular disorders or risk factors.
- •Presence of uncontrolled systemic disease.
- •Presence of clinically symptomatic or uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- •History of interstitial lung disease (ILD) or non-infectious pneumonitis.
- •Presence within 3 months before the first dose of other moderate to severe lung disorders.
- •Tumor invasion or compression of surrounding vital organs and major blood vessels.
- •Active severe digestive system diseases.
- •Unresolved toxicity from prior anti-tumor therapy.
- •Serious infection within 4 weeks before the first dose.
- •Presence of active HIV, hepatitis B or hepatitis C or co-infection with HBV and HCV.
- •Known history of allogeneic organ transplant or hematopoietic stem cell transplant.
- •History of allergy to any component of the study drug or severe hypersensitivity to other monoclonal antibodies.
- •Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.
- •Participants who have received other investigational drug treatments within 4 weeks before the first dose.
- •Pregnant or breastfeeding women.
- •Known history of psychosis or drug abuse that prevents the participant from cooperating with the study.
- •Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which may lead to higher medical risk and/or uncertainty in survival assessment, or may affect protocol compliance.
- •Any condition that, in the investigator's opinion, interferes with the evaluation of the investigational product, participant safety, or interpretation of study results, or any other condition that the investigator deems unsuitable for participation in this study.
研究组 & 干预措施
Cohort A: SKB571 monotherapy
Experimental
干预措施: SKB571 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to approximately 24 months.
ORR as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
次要结局
- Progression-free survival (PFS)(Up to approximately 24 months.)
- Duration of Response (DOR)(Up to approximately 24 months.)
- Disease control rate (DCR)(Up to approximately 24 months.)
- Overall Survival (OS)(Up to approximately 24 months.)
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)(Up to approximately 24 months.)
- Maximum Plasma Concentration (Cmax) of the investigational product(Up to approximately 24 months.)
- Minimum Plasma Concentration (Cmin) of the investigational product(Up to approximately 24 months.)
- Immunogenicity of the investigational product(Up to approximately 24 months.)
研究者
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