A Phase I Study Evaluating the Preliminary Efficacy and Safety of WTX212A Injection as Monotherapy or in Combination With Radiotherapy 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
- 12
- 试验地点
- 2
- 主要终点
- Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy
研究概览
简要总结
This is a single-arm, open-label, investigator-initiated clinical study (IIT) designed to evaluate the preliminary efficacy, safety, tolerability, immunogenicity, and pharmacokinetic (PK) characteristics of WTX212A Injection in patients with advanced solid tumors.
详细描述
This is a single-arm, open-label, investigator-initiated clinical study (IIT) designed to evaluate the preliminary efficacy, safety, tolerability, immunogenicity, and pharmacokinetic (PK) characteristics of WTX212A Injection in patients with advanced solid tumors. The study is divided into two phases: an initial exploratory phase and an expansion phase. The study includes two cohorts: Cohort A (WTX212A monotherapy) and Cohort B (WTX212A in combination with radiotherapy)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No Masking
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
- •Voluntarily signed informed consent, understanding of the study, and willingness and ability to complete all study procedures.
- •Male or female, aged 18 to 75 years (inclusive).
- •Patients with histologically and/or cytologically confirmed advanced malignant tumors.
排除标准
- •Suffering from other serious internal diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, liver cirrhosis, active bleeding, etc., those with uncontrollable or severe cardiovascular diseases, such as NYHA Class II or higher congestive heart failure, unstable angina, myocardial infarction, etc., within 6 months before the first dose, difficult to control hypertension (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥100mmHg).
- •Uncontrollable pleural effusion, peritoneal effusion, or pericardial effusion requiring puncture and drainage, or recurrence requiring re-drainage after puncture and drainage.
- •History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe lung function impairment.
- •Previous IO drug treatment with adverse events related to the drug that required permanent discontinuation of IO treatment.
研究组 & 干预措施
Experimental: Cohort B
Experimental: Cohort B Intervention: Drug: WTX212A+Radiotherapy
干预措施: WTX212A injection (Drug)
Experimental: Cohort A
Experimental: Cohort A Intervention: Drug: WTX212A Monotherapy
干预措施: WTX212A injection (Drug)
Experimental: Cohort B
Experimental: Cohort B Intervention: Drug: WTX212A+Radiotherapy
干预措施: radiotherapy (Radiation)
结局指标
主要结局
Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy
时间窗: From enrollment to the end of treatment，an average of 1 year
Disease Control Rate (DCR) of WTX212A monotherapy or WTX212A in combination with radiotherapy
次要结局
- Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy(Every 6 weeks until the end of the last treatment ，an average of 1 year)
- Safety of WTX212A monotherapy or WTX212A in combination with radiotherapy(From the first treatment to the end of the safety visit，an average of 1 year)
- Pharmacokinetic characteristics(Cmax)(Through study completion, an average of 1 year)
- Pharmacokinetic characteristics(Tmax)(Through study completion, an average of 1 year)
- Pharmacokinetic characteristics(AUC0-t)(Through study completion, an average of 1 year)
- Pharmacokinetic characteristics(t1/2)(Through study completion, an average of 1 year)
- Pharmacokinetic characteristics(CL)(Through study completion, an average of 1 year)
- Number of Anti-drug antibody (ADA)(Through study completion, an average of 1 year)
- Percentage of Anti-drug antibody (ADA)(Through study completion, an average of 1 year)
研究者
Rui-hua Xu, MD, PhD
Principal Investigator
Sun Yat-sen University