NCT07380386招募中1 期
A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB105 for Injection in Participants With Advanced Solid Tumors
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Number of subjects achieving Dose-limiting toxicity (DLT)
研究概览
简要总结
This is a Phase 1/2 clinical study to evaluate the safety and efficacy of SKB105 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage.
详细描述
This is a multicenter, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability, Pharmacokinetics(PK) characteristics, immunogenicity, and efficacy of SKB105 in participants with advanced solid tumors. The study includes a Phase 1 dose escalation stage, a Phase 1 dose expansion stage, and a Phase 2 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.
- •Participants should provide tumor tissue samples for biomarker testing as much as possible during the screening period;
- •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 effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage (>1 time/week).
- •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 meibomian gland disease and/or blepharitis, or a history of corneal diseases that hinder/delay corneal healing.
- •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
- •There is a risk of developing esophagotracheal fistula or esophageal pleural fistula, or tumor invasion or compression of surrounding important organs and blood vessels accompanied by related clinical symptoms.
- •Within 3 months prior to the first administration, there have been clinical symptoms of intestinal obstruction, gastrointestinal perforation or fistula, urethral fistula, and abdominal abscess.
- •Serious infection occurred within 4 weeks before 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 SKB105 injection or severe hypersensitivity reactions to other monoclonal antibodies.
- •Previously received drug therapy targeting Integrin β6(ITGB6) or any form of drug therapy containing topoisomerase I inhibitors.
- •Received chemotherapy, immunotherapy, biological therapy, or other large molecule anti-tumor drugs within 4 weeks before 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 of medication.
- •Those who have received treatment with other clinical investigational drugs within 28 days prior to their first administration.
- •Individuals who have previously received anti-tumor vaccines or have received any active vaccines within 28 days prior to their first treatment with the investigational drug.
- •Participants who received systemic corticosteroid therapy or other immunosuppressive drugs with>10 mg/day prednisone within 2 weeks prior to the first dose.
- •Within 14 days before the first administration or within 5 half lives of known drugs (whichever is longer), she received a strong inhibitor or strong inducer of cytochrome P450 or a breast cancer resistance protein (BCRP) inhibitor.
- •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
SKB105 monotherapy
Experimental
Subject will be dosed with SKB105 for injection every 3 weeks(q3w)
干预措施: SKB105 for injection Monotherapy (Drug)
结局指标
主要结局
Number of subjects achieving Dose-limiting toxicity (DLT)
时间窗: From date of initial dose until up to 21 days for treatment
DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during first 21 days and is at least possibly related to study drug.
Objective Response Rate (ORR)
时间窗: up to 3 years
The sum of the number of cases with Complete Response (CR) and Partial Response (PR) in all treated tumor patients (CR + PR) divided by the total number of cases.
次要结局
- Progression Free Survival (PFS)(Up to 3 years)
- Duration of Response (DOR)(Up to 3 years)
- Overall Survival (OS)(Up to 3 years)
研究者
研究点 (2)
Loading locations...
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