jRCT2031240279招募中不适用
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Subjects With Advanced Solid Tumors
GlaxoSmithKline K.K.0 个研究点目标入组 10 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
- 10
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
- Single Arm Study
- 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
- •Males or females aged 18 years or older (>-18 years).
- •Participants with pathologically confirmed advanced solid tumor (who have failed or are intolerant to standard of care).
- •Endometrial cancer cohort
- •Histologically documented, advanced (metastatic and/or unresectable) or recurrent endometrial cancer.
- •Must have received or are intolerant to 1 but no more than 2 lines of prior systemic therapy.
- •Must have had prior platinum and PD(L)-1 inhibitor (in same regimen or in separate regimens), if considered a candidate for this regimen and the regimen is locally available.
- •Maintenance therapy will be considered part of the preceding line of therapy (ie, not counted independently
- •All epithelial histologies are permitted including carcinosarcoma.
- •Participants have at least one target lesion as assessed per the RECIST 1.1
- •Tumor tissue from a newly obtained biopsy or archival tumor tissue is required for retrospective detection of B7 homolog 4 (B7-H4) expression by Immunohistochemistry (IHC) in central laboratory and other biomarker analysis. Tissue from a newly obtained biopsy is preferred. If a newly obtained biopsy is not feasible, archival tumor tissue within 2 years prior to the first dose of study drug is acceptable.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2 and no deterioration within 2 weeks before the first dose.
- •Have a life expectancy of at least 12 weeks.
排除标准
- •Have received any of B7-H4-targeted therapies.
- •Have received any of cytotoxic chemotherapy drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 28 days prior to the first dose of study drug; or need to continue these drugs during the study.
- •Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study treatment.
- •Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion
- •Major surgery within 4 weeks prior to the first dose of study treatment.
- •Evidence of brain metastasis unless asymptomatic.
- •Has inadequate bone marrow reserve or hepatic/renal functions.
- •Mean Fridericia-corrected QT interval (QTcF) > 470 millisecond (msec) on resting ECG.
- •Evidence of current clinically significant arrhythmias or ECG abnormalities
- •Risk factors of prolonged QTc or arrhythmia events,
- •Left ventricular ejection fraction (LVEF) < 50%.
- •Have severe, uncontrolled or active cardiovascular 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 pneumonitis requiring high-dose systemic glucocorticoids.
- •Have received prior therapy with topoisomerase inhibitors or topoisomerase inhibitor Antibody-drug conjugate (ADCs)
- •Endometrial cancer: Mesenchymal tumors of the uterus (uterine sarcomas) not permitted.
研究者
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