A Phase I Clinical Study of the Safety, Pharmacokinetics, and Antitumor Activity of SSS59 in Patients With Advanced Malignant Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- DLTs
研究概览
简要总结
This study was an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSS59 as a single agent in patients with advanced malignancies.
详细描述
This study includes 4 Parts: Part A1 (dose escalation and dose extension for QW administration), Part A2 (dose escalation and dose extension for Q2W administration), Part A3 (dose extension for Q3W administration), and Part B (indication extension, such as advanced gastric or gastroesophageal junction adenocarcinoma with MUC17 positive, failure of standard therapy, or intolerance to standard therapy , or other tumors).
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
- •Histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Expected survival >3 months.
- •Signed informed consent form.
- •Must have adequate organ function.
排除标准
- •Any remaining AEs > grade 1 from prior anti-tumor treatment as per CTCAE v
- •0, with exception of hair loss and fatigue.
- •Pregnant or nursing women or women/men who are ready to give birth.
- •symptomatic central nervous system metastasis.
- •Allergy to other antibody drugs or any excipients in the study drugs.
- •Underwent major surgery within 4 weeks prior to first dosing.
- •The patient is participating in another clinical study, unless it is an observational (non-intervention) clinical study or a follow-up period of an intervention study.
- •The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
Part A1
Dose escalation will be conducted using accelerated titration and traditional 3+3 design. Dose Escalation Level includes 12 levels, QW IV. Dose extension will be carried out at the selected level.
干预措施: SSS59 (Drug)
Part A2
Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation Level includes 12 levels, Q2W IV. Dose extension will be carried out at the selected level.
干预措施: SSS59 (Drug)
Part A3
Dose extension will be carried out at the selected dose level, Q3W, IV.
干预措施: SSS59 (Drug)
Part B
Indication extension will be carried out at the selected level.
干预措施: SSS59 (Drug)
结局指标
主要结局
DLTs
时间窗: 21 days
Dose limiting toxicity
Safety and tolerability
时间窗: during the intervention，Within 28 days of the last dose
Safety and tolerability assessed by incidence and severity of adverse events
MTD and RP2D
时间窗: through study completion, an average of 2 year
Determine the maximum tolerated dose and determine the recommended phase II dose
次要结局
- Cmax of SSS59(baseline, during the intervention and at the end of the study)
- Tmax of SSS59(baseline, during the intervention and at the end of the study)
- AUC0-last of SSS59(baseline, during the intervention and at the end of the study)
- RO of SSS59(baseline, during the intervention and at the end of the study)
- Pharmacodynamic (PD) characteristics of SSS59(baseline, during the intervention and at the end of the study)
- Immunogenicity of SSS59(baseline, during the intervention and at the end of the study)
- Preliminary antitumor activity of SSS59(baseline, during the intervention and at the end of the study)