NCT07844447尚未招募1 期
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RT036 in Participants With Advanced Malignant Solid Tumors
Shanghai Ruotuo Biosciences Co., Ltd.0 个研究点目标入组 308 人开始时间: 2026年10月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 308
- 主要终点
- AE
研究概览
简要总结
This study is a Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of RT036 in Subjects with Advanced Malignant Solid Tumour.
In dose escalation and dose expasion phase, the safety, tolerability of RT036 in patients with advanced malignant solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), recommended phase 2 dose (RP2D) of RT036.
In clinical expansion phase, the preliminary antitumor activity of RT036 in target solid tumors will be evaluated.
In addition, the pharmacokinetic characteristics, and immunogenicity of RT036 in patients with advanced malignant solid tumors will be evaluated.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 序贯
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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
- Male or female participants aged 18 years or older at the time of signing the informed consent form (ICF)
- Participants with histologically or cytologically confirmed advanced malignant solid tumors;
- Participants with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Participants with an expected survival ≥ 12 weeks;
- Participants must have at least one measurable lesion based on RECIST v1.1; In dose escalation phase, participants without measurable lesions are permitted.
排除标准
- Participants with active central nervous system (CNS) metastases are excluded. However, participants are eligible if they have previously received radiotherapy or surgery, and imaging within 4 weeks prior to the first dose shows stable brain metastases without progression or new neurological symptoms, and corticosteroids have been withheld for at least 2 weeks prior to first dose. Participants with leptomeningeal or brainstem metastasis are not eligible regardless of treatment status;
- Participants with clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring repeated intervention, or with a history of hypertensive crisis or hypertensive encephalopathy;
- Participants with poorly controlled hypertension (defined as repeated measurements of systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite antihypertensive therapy), or with a history of hypertensive crisis or hypertensive encephalopathy;
- Participants with a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that requiring corticosteroid therapy (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, radiation pneumonitis, idiopathic pneumonitis, etc.), or participants with current ILD/non-infectious pneumonitis;
- Participants with clinically significant intercurrent lung-specific illnesses, including but not limited to any underlying pulmonary diseases diagnosed within 3 months prior to the first dose (e.g., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, etc.), any autoimmune, connective tissue, inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or prior pneumonectomy;
- Participants with a history of immunodeficiency, including a positive test for human immunodeficiency virus (HIV), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Participants with any other conditions that may lead to premature discontinuation from the study, such as severe physical or psychiatric illness or laboratory abnormalities, which may increase the risk of study participation, affect treatment compliance, or interfere with the interpretation of study results, and who are deemed unsuitable for enrollment by the investigator.
研究组 & 干预措施
RT036
Experimental
Participants with advanced solid tumors will receive pre-defined doses of RT036
干预措施: RT036 for injection (Drug)
结局指标
主要结局
AE
时间窗: Up to 36 months
Incidence and severity of adverse events
DLT
时间窗: Up to 12 months
Incidence of dose-limiting toxicities (DLTs)
MTD
时间窗: Up to 12 months
To determine the maximum tolerated dose
RP2D
时间窗: Up to 12 months
To determine the recommended phase 2 dose
次要结局
- ORR(Up to 36 months)
- DCR(Up to 36 months)
- DoR(Up to 36 months)
- PFS(Up to 36 months)
- OS(Up to 36 months)
研究者
标识符
- NCT 编号
- NCT07844447
- 其他研究编号
- RT036-001-I/II
日期
- 首次提交
- (9天前)
- 首次发布
- (前天)
- 主要完成日期
- (3年后)
- 研究完成日期
- (3年后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
相似试验
尚未招募
1 期
同适应症 · 同分期A Study of RT023 in Patients With Advanced Solid TumorsAdvanced Malignant Solid TumoursNCT07797426Shanghai Ruotuo Biosciences Co., Ltd.318
已完成
1 期
同适应症 · 同分期PDM08 Clinical Trial in Advanced Solid TumorsMalignant Solid TumoursNCT01380249Prodimed S.A.22
招募中
1 期
同适应症 · 同分期Allogeneic γδ T Cell Therapy for the Treatment of Solid TumorsMalignant Solid TumoursNCT04765462Chinese PLA General Hospital60
尚未招募
1 期
同适应症 · 同分期Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB14 in Adult Patients With Advanced Malignant Solid Tumours.Advanced Malignant Solid TumoursNCT06304818Sinocelltech Ltd.515
招募中
1 期
同适应症 · 同分期Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB41 in Adult Patients with Advanced Malignant Solid Tumours.Advanced Malignant Solid TumoursNCT06600022Sinocelltech Ltd.441