NCT06418061招募中1 期
A Multicenter, Open-label, Phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI3005 in Subjects with Advanced Malignant Solid Tumors
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Number of subjects with clinically significant changes in vital signs
研究概览
简要总结
The main purpose of this study is to evaluate the safety and tolerability of IBI3005 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3005.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Subjects Should have been previously treated with a third-generation EGFR TKI with disease progression. Subjects with positive other driver genes or METex14 mutations are required to undergo targeted therapy and disease progression.
排除标准
- •Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study.Patients are allowed to receive inactivated vaccines.
- •Uncontrolled diseases including:
- •Infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first dose of the study drug（ antiviral medication for hepatitis B and hepatitis C infection that are compliant with the protocol were allowed）;
- •Known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1/2 Ab positive);
- •Acute or chronic active hepatitis B (HbsAg positive and/or HbcAb positive with HBV DNA titer ≥ 104 copies/mL or ≥ 2000 IU/mL or higher than lower limit of detection) or C (HCV Ab positive with HCV RNA titer > 103 copies/mL or higher than lower limit of detection);
- •Active COVID-19 infection with obvious symptoms requiring treatment or hospitalization, such as pyrexia, dyspnea, nausea, vomiting, diarrhea, etc.;
- •Active tuberculosis infection, or still on anti-tuberculosis therapy or received anti tuberculosis therapy within 1 year prior to first administration of the study drug;
- •Active syphilis infection or latent syphilis requiring treatment;
- •Symptomatic congestive heart failure Grade II-IV (New York Heart Association [NYHA]), symptomatic or uncontrolled arrhythmias, QTc interval > 480 ms or personal or family history of congenital long/short QT syndrome;
- •Hypertension that does not receive standardized therapy or still uncontrollable hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg); Any history of life-threatening hemorrhage, or hemorrhage requiring (including but not limited to gastrointestinal bleeding, hemoptysis, etc) blood transfusion, endoscopy, or surgery, within 3 months prior to the first administration of study drug;
研究组 & 干预措施
IBI3005
Experimental
干预措施: IBI3005 (Drug)
结局指标
主要结局
Number of subjects with clinically significant changes in vital signs
时间窗: Up to 3 years
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
Numbers of subjects with adverse events
时间窗: Up to 3 years
defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Number of subjects with clinically significant changes in physical examination results
时间窗: Up to 3 years
Clinically significant abnormal physical examination findings reported by the investigator.
Dose limiting toxicities (DLTs)
时间窗: Up to 4 weeks
Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.
次要结局
- anti-drug antibody (ADA)(up to 3 years)
- clearance (CL)(up to 3 years)
- apparent volume of distribution (V)(up to 3 years)
- half-life (t1/2)(up to 3 years)
- area under the curve (AUC)(up to 3 years)
- maximum concentration (Cmax)(up to 3 years)
- time to maximum concentration (Tmax)(up to 3 years)
- objective response rate (ORR)(up to 3 years)
- duration of response (DoR)(up to 3 years)
- time to response (TTR)(up to 3 years)
- progression free survival (PFS)(up to 3 years)
研究者
研究点 (1)
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