jRCT2031240381招募中不适用
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of GSK5764227 in Participants with Advanced Solid Tumors
GlaxoSmithKline K.K.0 个研究点目标入组 15 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 主要终点
- Number of participants with Adverse Events (AEs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Male or female participants at least 18 years of age (>-18 years)
- •Participants with histologically confirmed advanced/metastatic solid tumors, irrespective of mutational status, as defined per study phase and cohort, as follows:
- •Participants with advanced/metastatic tumors who have progressed on or are intolerant to all available standard of care therapies.
- •Participants with selected advanced/metastatic solid tumors who have progressed on one or more prior lines of therapy.
- •Has measurable disease (i.e., at least 1 target lesion) per RECIST v1.1, as determined by the investigator.
- •Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before first dose.
- •Has a life expectancy >12 weeks.
- •Has adequate organ function. Specimens must be collected within 3 days prior to the start of study intervention administration.
- •Where available, participants should provide a formalin fixed and paraffin embedded (FFPE) tumor sample from the most recent biopsy of primary cancer or from a metastatic site for central testing. Tumor tissue (archival tumor tissue or a fresh biopsy) is required unless an exemption is granted by the medical monitor. Tumor tissue is necessary for retrospective detection of B7 homolog 3 protein (B7-H3) expression by Immunohistochemistry (IHC) in central laboratory and other biomarker analysis.
排除标准
- •Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to <-Grade 1 or to the baseline status preceding prior therapy.
- •Prior treatment with orlotamab, enoblituzumab, I-Dxd, or other B7-H3 targeted agents.
- •Evidence of brain metastasis (unless meeting the following criteria at the same time: asymptomatic; medically stable for at least 4 weeks prior to initial dosing; no steroid treatment required for at least 2 weeks prior to initial dosing; and no imaging evidence of severe edema located around the tumor lesion); or untreated progression due to brain metastasis during or after the last treatment prior to screening; or evidence of meningeal/brainstem metastasis; or evidence of spinal cord compression (detected by radiographic examination, symptomatic or not).
- •Any of the following cardiac examination abnormality:
- •Has QT interval, corrected for heart rate (QTc) >450 msec or QTc >480 msec for participants with bundle branch block.
- •Evidence of current clinically significant arrhythmias or ECG abnormalities (e.g., complete left bundle branch block, third-degree atrioventricular [AV] block, second-degree AV block, PR interval >250 msec).
- •Risk factors of prolonged QTc or arrhythmia events, such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death of any direct relative under 40 years old or any concomitant medications that prolong the QT interval.
- •Left ventricular ejection fraction (LVEF) <50%.
- •Has severe, uncontrolled or active CV disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events.
- •Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids.(Japan-Specific Requirements) Any evidence of current pneumonitis or ILD, or a prior history of pneumonitis requiring high-dose systemic glucocorticoids or ILD.
结局指标
主要结局
Number of participants with Adverse Events (AEs)
Number of participants with Adverse Events (AEs)
Number of participants with Dose Limiting Toxicities (DLTs)
Number of participants with Dose Limiting Toxicities (DLTs)
Number of participants with AEs and serious adverse events (SAEs) by severity
Number of participants with AEs and serious adverse events (SAEs) by severity
Number of participants with AEs leading to dose modifications
Number of participants with AEs leading to dose modifications
Number of participants with changes in vital signs, body weight, laboratory tests, electrocardiogram (ECG) and Eastern Cooperative Oncology Group (ECOG) performance status
Number of participants with changes in vital signs, body weight, laboratory tests, electrocardiogram (ECG) and Eastern Cooperative Oncology Group (ECOG) performance status
Progression-free survival (PFS)
Progression-free survival (PFS)
Objective Response Rate (ORR)
Objective Response Rate (ORR)
次要结局
- Trough concentration (Ctrough) of GSK5764227(Phase 1a and Phase 1b)
研究者
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