A Multicenter, Dose-Escalation and Expansion Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Efficacy of SGT003 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 332
- 试验地点
- 1
- 主要终点
- Adverse Events (AEs), immune-related Adverse Events (irAEs)
研究概览
简要总结
A Phase I/IIa clinical study SGT003 in patients with advanced solid tumors.
详细描述
This is a first-in-human Phase I/IIa clinical study evaluating the safety, tolerability, pharmacokinetic (PK) characteristics, immunogenicity, and preliminary efficacy of SGT003 in patients with advanced solid tumors. The study comprises a Phase I (dose-escalation) stage and a Phase IIa (dose-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
- •Patient can fully understand the trial, participates voluntarily, and signs informed consent form (ICF) prior to any study procedures
- •Patients aged 18 to 75 years at the time of ICF signature.
- •Study population:
- •Phase I (dose-escalation study): Patients with advanced solid tumors confirmed histologically or cytologically, who have failed at least one standard therapy for advanced disease, are intolerant to standard therapy, or have no available standard treatment options.
- •Phase IIa (dose-expansion study): Patients with advanced solid tumors who have received at least first-line but not up to third-line standard systemic therapy and experienced disease progression or intolerance to such therapy.
- •Radiographic evidence (CT/MRI, etc.) of disease progression documented during or after the most recent prior treatment.
- •Patients must have adequate bone marrow reserve and organ function.
排除标准
- •Subjects who have received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunosuppressive therapy or other anti-tumor therapy within 4 weeks prior to the first administration of the investigational product.
- •Subjects who have received systemic immunosuppressant therapy within 14 days prior to the first administration of the investigational product.
- •Subjects receiving anticoagulants such as therapeutic-dose heparin or vitamin K antagonists.
- •Subjects who have received any live or attenuated live vaccine within 28 days prior to the first administration of the investigational product.
- •Subjects who have undergone major surgery within 4 weeks prior to the first administration of the investigational product.
- •Subjects with a history of Grade ≥3 immune-related adverse events (irAEs), hypersensitivity reactions, or Grade ≥2 immune-related myocarditis.
- •Subjects with active autoimmune disease or prior autoimmune disease with a risk of recurrence. Exceptions: well-controlled type 1 diabetes, hypothyroidism controlled solely by hormone replacement therapy, and skin diseases that do not require systemic treatment.
- •Subjects with current or prior active interstitial lung disease (ILD). Subjects with radiation-induced pulmonary fibrosis that does not require steroid therapy are eligible.
研究组 & 干预措施
SGT003
Use SGT003 for Injection
干预措施: SGT003 (Drug)
结局指标
主要结局
Adverse Events (AEs), immune-related Adverse Events (irAEs)
时间窗: First dose up to 28 days (+3 days) after EOT, or prior to initiation of other anti-tumor therapy, whichever occurs first.
This includes clinically significant changes in vital signs, physical examination, electrocardiogram, echocardiogram and clinical laboratory tests, as graded by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 6.0.
Phase I: Dose Limit Toxicity (DLTs)
时间窗: Within the first dose cycle (Day1-Day21) of SGT003
Evaluated at each dose level of SGT003 graded by NCI CTCAE v6.0.
Phase I: Maximum Toxicity Dose（MTD）
时间窗: Within the first dose cycle (Day1-Day21) of SGT003
The MTD is based on the incidence of DLTs
Phase I: Recommended Phase II dose (RP2D)
时间窗: Within the first dose cycle (Day1-Day21) of SGT003
The RP2D is based on the results of safety、PK/PD and preliminary efficacy of SGT003 in the stage of dose escalation
Phase IIa: Objective Response Rate (ORR)
时间窗: from date of randomization, until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, death, loss to follow-up, or study termination, whichever occurs first. average Up to 24 months
The ratio of CR and PR Evaluated by RECIST1.1 and iRECIST,
次要结局
- Area under the plasma concentration-time curve (AUC)(From first study treatment to EOT, average of 24 months)
- Peak concentration (Cmax)(From first study treatment to EOT, average of 24 months)
- Time to peak concentration(Tmax)(From first study treatment to EOT, average of 24 months)
- Immunogenicity(Starting from the first administration of investigational product until 28 days (+3 days) after EOT.)