NCT06560138撤回1 期
An Open-label, Multi-center Phase I Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-4602 in Subjects With HER2-expressing or HER2-mutated Locally Advanced or Metastatic Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- the phase II dose (RP2D) of SHR-4602
研究概览
简要总结
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-4602 in subjects with HER2-expressing or HER2-mutated locally advanced or metastatic solid tumors.
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
- •Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
- •ECOG PS score 0 or 1
- •Life expectancy ≥ 12 weeks
- •Adequate bone marrow and other vital organ functions
- •Adequate liver function tests
- •HER 2 exprission advanced solid tumor
排除标准
- •Inclusion Criteria
- •Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
- •ECOG PS score 0 or 1
- •Life expectancy ≥ 12 weeks
- •Adequate bone marrow and other vital organ functions
- •Adequate liver function tests
- •HER 2 exprission advanced solid tumor
- •Exclusion Criteria
- •Active brain metastases, carcinomatous meningitis/leptomeningeal metastases.
- •Have received surgery (eg. major surgerical treatment for cancer), chemotherapy, molecular targeted therapy, immunotherapy, cell therapy, or radiotherapy within 4 weeks prior to the first dose of investigational drug (palliative radiotherapy within 2 weeks prior to the first dose).
- •Participated in another clinical study with the last dose of study drug received in less than 4 weeks prior to the first dose.
- •Subjects with toxicities and/or complications from prior treatment not recovered to NCI-CTCAE Grade ≤
- •History of pleural fluid, ascites, or pericardial effusion requiring intervention within 2 weeks prior to the first dose.
- •History of active autoimmune diseases.
- •History of hereditary or acquired bleeding disorders or thrombotic tendency
- •Active hepatitis B (defined as hepatitis B virus surface antigen [HBsAg] positive and serum HBV-DNA copy ≥ 500 IU/mL), hepatitis C
- •History of severe infection within the past 30 days, including but not limited to bacteremia, severe sepsis, pneumonia requiring hospitalization
- •Other malignancies currently or within the past 5 years, except for cured cervical carcinoma in situ
- •Allergy to any component or excipient of the SHR-4602 product,
- •History of severe medical, psychiatric, or social conditions deemed by the investigator to be likely to interfere with a subject's ability to understand, consent, cooperate and participate in the study.
- •Patients with Grade≥2 peripheral neuropathy, except for those with mild symptoms that do not require treatment
研究组 & 干预措施
SHR-4602 Dose level 1 : 2.0 mg/kg, Dose level 2 : 2.5mg/kg
Experimental
干预措施: SHR-4602 (Drug)
结局指标
主要结局
the phase II dose (RP2D) of SHR-4602
时间窗: From the time when the subjects sign the informed consent form to 45(±3) days after the last dose of SHR-4602, or the start of new anti-tumor treatment (whichever comes first).assessed for a maximum duration of up to 1 year
RP2D is defined as the dose of SHR-4602 recommended for efficacy study in Phase II. It will be the dose with promising clinical responses observed in the subjects, well tolerated by subjects without exceeding a pre-set number of adverse events.
次要结局
- Objective Response Rate (ORR)(From the first date with measurable disease meeting the CR or PR criteria, to the date of PD or death from any cause, whichever occurs first. assessed for a maximum duration of up to 3 years)
- Duration of Response (DoR)(From the first date with measurable disease meeting the CR or PR criteria, to the date of PD or death from any cause, whichever occurs first. assessed for a maximum duration of up to 3 years)
- Disease Control Rate (DCR)(From the first date with measurable disease meeting the CR, PR or SD criteria, to the date of PD or death from any cause, whichever occurs first. assessed for a maximum duration of up to 3 years.)
- Progression Free Survival (PFS)(From the first dose of SHR-4602 to the first PD or death from any cause (whichever occurs first). assessed for a maximum duration of up to 3 years)
- Cmax(Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year)
- Tmax(Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year)
- Css, max,(Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year)
- AUC0-∞(Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year)
- AUCτ(Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year)
- t1/2(Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year)
- Css, min(Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year)
- AUC0-t(Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year)
- Vss(Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year)
- MRT(Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year)
- Rac(Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year)
- anti-SHR-4602 antibody (ADA)(Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year)
- CL(Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year)
研究者
研究点 (5)
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