NCT07545265招募中1 期
A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB565 for Injection in Participants With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- Number of subjects achieving Dose-limiting toxicity (DLT)
研究概览
简要总结
This is a phase I/II clinical study to evaluate the safety and efficacy of SKB565 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage.
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
- •Participants voluntarily joined this study and signed an informed consent form.
- •The age at the time of signing the informed consent form must be between 18 and 75 years.
- •Participants with histologically or cytologically confirmed advanced solid tumors who have failed standard therapy, have no standard therapy available, or are intolerant to standard therapy.
- •Researchers evaluated based on Response Evaluation Criteria in Solid Tumors(RECIST) Version 1.1 that there is at least one measurable lesion present.
- •Eastern Cooperative Oncology Group (ECOG) score is 0 or
- •Expected survival period ≥ 12 weeks.
- •Participants have sufficient bone marrow, liver, kidney, and coagulation functions.
- •Male and female participants must agree to use highly effective contraceptive methods during the study period.
排除标准
- •Participants known to have meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, and active central nervous system (CNS) metastasis.
- •Patients with other malignant tumors within 3 years before the first administration.
- •There are serious heart or vascular diseases or high-risk factors present.
- •According to researchers' judgment, it is an uncontrollable systemic disease.
- •There are pleural, pericardial, or ascitic effusions that are poorly controlled, symptomatic, or requiring repeated drainage.
- •History of interstitial lung disease or non infectious pneumonia.
- •There are other lung diseases that may interfere with drug-related pulmonary toxicity.
- •Severe dry eye syndrome, severe conjunctivitis, severe meibomian gland disease and/or blepharitis, or a history of corneal diseases that hinder/delay corneal healing.
- •Presence of esophagotracheal fistula or esophagoaortic fistula, or tumor invasion or compression of surrounding vital organs and blood vessels accompanied by corresponding clinical symptoms.
- •Within 3 months prior to the first administration, there have been intestinal obstruction, gastrointestinal perforation or fistula, urethral fistula, and abdominal abscess.
- •The toxicity of previous anti-tumor treatments has not been relieved, defined as the toxicity has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0 grade 0 or
- •Serious infection occurred within 28 days prior to the first administration.
- •Active hepatitis B or C, or simultaneous infection with Hepatitis B virus(HBV) and Hepatitis C virus(HCV).
- •Human immunodeficiency virus (HIV) test is positive or there is a history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection.
- •Known active pulmonary tuberculosis.
- •Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.
- •History of allergies to any components of SKB565 injection or severe hypersensitivity reactions to other monoclonal antibodies.
- •Received chemotherapy, immunotherapy, biological therapy, or other large-molecule antitumor drugs within 28 days prior to the first administration. Received small-molecule targeted therapy or approved antitumor Chinese patent medicine preparations within 14 days prior to the first administration.
- •Within 6 months prior to the first administration, lung lesions received radiation therapy with a total dose greater than 30 Gray.
- •Have undergone major surgical procedures or suffered serious injuries within 28 days prior to the first administration.
- •Those who have received treatment with other clinical investigational drugs within 28 days prior to the first administration.
- •Individuals who have previously received anti-tumor vaccines or have received any active vaccines within 28 days prior to the first administration.
- •Pregnant or lactating women.
- •Participants with a known history of mental illness or substance abuse are unable to cooperate in completing the study.
- •Suffering from local or systemic diseases caused by non malignant tumors, or diseases or symptoms secondary to tumors, which may affect compliance.
- •Any condition that the researcher deems to interfere with the evaluation of the investigational drug, the safety of participants, or the interpretation of research results, or any other condition that the researcher deems unsuitable for participation in this study.
研究组 & 干预措施
SKB565 monotherapy
Experimental
SKB565 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle
干预措施: SKB565 (Drug)
结局指标
主要结局
Number of subjects achieving Dose-limiting toxicity (DLT)
时间窗: Day 1 to Day 28 in Cycle 1 in the dose escalation part
DLT is defined as an adverse event (AE) that meets protocol-defined DLT criteria during the first 28 days and is at least possibly related to the study drug.
Objective response rate (ORR)
时间窗: Up to approximately 3 years
To evaluate the ORR of SKB565 as assessed by the investigator based on RECIST v1.1.
Number of subjects achieving Dose-limiting toxicity (DLT)
时间窗: At the end of Cycle 1 of the dose-escalation phase (each cycle is 28 days)
DLT is defined as an adverse event (AE) that meets protocol-defined DLT criteria during the first 28 days and is at least possibly related to the study drug.
次要结局
未报告次要终点
研究者
研究点 (4)
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