NCT07050641招募中1 期
An Open Multi-center Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB39-1 in Adult Patients With Advanced Malignant Solid Tumours
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Dose-Limiting toxicity(DLT)
研究概览
简要总结
This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB39-1 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the informed consent form (ICF);
- •Male or female, over 18 years old;
- •Survival duration more than 3 months;
- •ECOG score ≤ 1 point;
- •Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour;
- •Participants in Phase Ib (dose-expansion phase) and Phase II are required to meet the following criteria: Histologically or cytologically confirmed specific type advanced malignant solid tumours;
- •At least one measurable tumor lession according to RECIST v1.1;
- •Adequate organ and bone marrow function.
排除标准
- •Has participated in another clinical study within 4 weeks prior to the first dose;
- •Other malignancies diagnosed within 5 years prior to the enrollment;
- •Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;
- •Significant bleeding risk;
- •Presence of pleural effusion, peritoneal effusion, or ascites;
- •History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;
- •Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;
- •History of severe allergies, severe drug allergies (including unapproved investigational drugs);
- •History of organ transplantation or stem cell transplantation;
- •Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;
- •Received chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks before enrollment;
- •Pregnant or breastfeeding female.
研究组 & 干预措施
SCTB39-1
Experimental
SCTB39-1 of different doses, IV, every 3 weeks
干预措施: SCTB39-1 (Drug)
结局指标
主要结局
Dose-Limiting toxicity(DLT)
时间窗: From Day 0 up to Day 21
Incidence of dose-limiting toxicities up to the Day 21 visit
Objective response rate (ORR)
时间窗: Up to 2 years
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
次要结局
- Progression-free survival (PFS)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Overall survival (OS)(Up to 2 years)
研究者
研究点 (1)
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