NCT07774624尚未招募1 期
A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB103 in Participants With Locally Advanced, Recurrent, or Metastatic HER2-negative Breast Cancer.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 140
- 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 SKB103 in participants with advanced (locally advanced, recurrent, or metastatic) HER2-negative breast cancer. The study includes a Phase 1 dose escalation stage and a Phase 2 indication expansion stage.
详细描述
This is a multi-center, open-label, phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and efficacy of SKB103 in participants with locally advanced, recurrent or metastatic HER2-negative breast cancer.
The study includes a Phase 1 dose escalation 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
- •Willingness to participate in the study, sign the informed consent form(ICF), and comply with the protocol-specified visits and relevant procedures.
- •Aged ≥ 18 and ≤ 75 years at the time of signing ICF.
- •Histologically and/or cytologically confirmed HER2-negative Breast cancer who have failed standard therapy.
- •Participants should provide tumor tissue samples for biomarker testing as much as possible.
- •At least one measurable lesion per RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) score is 0 or
- •Life expectancy ≥ 12 weeks.
- •Acceptable bone marrow and organ function.
- •Male and female participants must agree to use highly effective contraceptive methods during the study period.
排除标准
- •Participants with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, and active central nervous system (CNS) metastases.
- •Participants with other malignant tumors within 3 years prior to the first administration.
- •Presence of any serious cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
- •Presence of any uncontrolled systemic disease, as judged by the investigator.
- •Presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
- •History of interstitial lung disease or noninfectious pneumonitis.
- •Other lung diseases that may interfere with drug-related pulmonary toxicity or may cause clinically serious lung injuries.
- •Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disorders that prevent/delay corneal healing.
- •Presence of risk of developing esophagotracheal fistula or esophageal pleural fistula, or tumor invasion or compression of surrounding vital organs and major blood vessels with related clinical symptoms.
- •Clinical symptoms of intestinal obstruction, gastrointestinal perforation or fistula, urethral fistula, and abdominal abscess within 3 months prior to the first administration.
- •Toxicities from prior anti-tumor therapy not recovering to ≤ Grade
- •Has experienced immune-related adverse events (irAE) of Grade 3 or higher during prior immunotherapy
- •Serious infection occurred within 4 weeks prior to the first administration.
- •Active hepatitis B or hepatitis C.
- •Positive result of human immunodeficiency virus (HIV) test or 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 component of SKB103 injection, or severe hypersensitivity reaction to other monoclonal antibodies.
- •Has received prior antibody or drug therapy targeting T-cell co-stimulatory or checkpoint pathways, or cell therapy.
- •Received chemotherapy, immunotherapy, biological therapy, or other large molecule anti-tumor drugs within 4 weeks prior to the first administration.
- •Has received radiation therapy to lung lesions with a total dose >30 Gy within 6 months prior to the first dose of study drug.
- •Participants who received major surgeries 4 weeks prior to the first administration.
- •Participants who received other investigational drugs within 4 weeks prior to their first administration.
- •Participants who have previously received anti-tumor vaccines or have received any live vaccines within 4 weeks prior to the first administration or scheduled to receive live vaccines during study treatment.
- •Receipt of systemic corticosteroid therapy (>10mg of prednisone or its equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose.
- •Receipt of strong inhibitors or inducer of cytochrome P450（CYP3A4） or inhibitors of breast cancer resistance protein (BCRP) within 2 weeks prior to the first administration or within 5 half-lives of the known drugs(whichever is longer).
- •Pregnant or lactating women.
- •Known history of psychiatric disorder or substance abuse that may interfere with study compliance.
- •Has any local or systemic condition (non malignant or tumor related) that may impair protocol compliance.
- •Any condition that, in the opinion of the Investigator, may interfere with the evaluation of the study drug, participant safety, or interpretation of the study results; or any other condition that the investigator deems unsuitable for participation in this study.
结局指标
主要结局
Number of subjects achieving Dose-limiting toxicity (DLT)
时间窗: Within the first 21 days following the initial dose.
DLT is defined as any adverse event (AE) that meets protocol-defined DLT criteria, occurring in the first 21 days, and considered at least possibly drug-related.
Objective response rate(ORR)
时间窗: Up to approximately 3 years
ORR is defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) as the best overall response assessed per RECIST 1.1.
次要结局
- Progression-free survival (PFS)(Up to approximately 3 years)
- Duration of Response (DOR)(Up to approximately 3 years)
- Disease control rate (DCR)(Up to approximately 3 years)
- Overall Survival (OS)(Up to approximately 3 years)
- Cmax(Up to approximately 3 years)
- Cmin(Up to approximately 3 years)
- Immunogenicity(Up to approximately 3 years)
研究者
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