A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- AE
研究概览
简要总结
This study was an open-label phase I study to evaluate the safety, tolerability, PK profile and potential efficacy of SSGJ-705 as a single agent in patients with advanced malignancies.
详细描述
This study includes 4 Parts: Part 1 (dose escalation and dose extension for QW administration), Part 2 (dose escalation and dose extension for Q2W administration), Part 3 (dose escalation and dose extension for Q3W administration), and Part 4 (indication extension, such as HER2 expression, PD-L1 high expression, driver gene negative newly treated advanced NSCLC, or other tumors).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Males and/or females over age 18
- •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, fatigue, and grade 2 peripheral neurotoxicity.
- •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.
- •Severe dyspnea at rest due to complications of advanced malignant tumors, or needing supplemental oxygen therapy.
- •Participated in any clinical study of medical devices or drugs within 1 month prior to screening (excluding non-intervention clinical studies or follow-up period of intervention clinical studies) .
- •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 1
Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation includes 6 levels, QW IV. Dose extension will be carried out at the selected level.
干预措施: SSGJ-705 (Drug)
Part 2
Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation includes 6 levels, Q2W IV. Dose extension will be carried out at the selected level.
干预措施: SSGJ-705 (Drug)
Part 3
Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation includes 6 levels, Q3W IV. Dose extension will be carried out at the selected level.
干预措施: SSGJ-705 (Drug)
Part 4
Indication extension will be carried out at the selected level，including 3 dosage levels.
干预措施: SSGJ-705 (Drug)
结局指标
主要结局
AE
时间窗: up to 1 year
Safety and tolerability assessed by incidence and severity of adverse events
MTD or MAD
时间窗: up to 1 year
maximum tolerated dose or the maximum administered dose if MTD is not reached
RP2D
时间窗: up to 1 year
the recommended phase II dose
DLTs
时间窗: 14 days
Dose limiting toxicity
次要结局
- T1/2(up to 1 year)
- PFS(up to 1 year)
- Cmax(up to 1 year)
- ORR(up to 1 year)