jRCT2031250763尚未招募不适用
A Phase 1, open-label, multicenter study of GSK5533524 alone or in combination with other anti-cancer agents, in adult participants with selected advanced solid tumors
未提供0 个研究点目标入组 12 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
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
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Is at least 18 years of age or the legal age of consent
- •Has histologically or cytologically confirmed advanced/metastatic solid tumor that is refractory to standard therapy, for which no standard treatment is available, or who is intolerant to established standard of care therapies.
- •Has documented disease progression based on radiologic imaging, during or after most recent line of treatment.
- •Has at least one target lesion per RECIST 1.1 (participants in Part 1a backfill and Part 1b).
- •Has an Eastern Cooperative Oncology Group performance status of 0 or 1 and no deterioration in the 2 weeks before enrollment.
- •Has adequate organ function.
排除标准
- •Has a history of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, congestive heart failure or clinically significant arrhythmia not controlled by Standard of care therapy.
- •Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion.
- •Has untreated brain or central nervous system metastases or metastases that have progressed
- •Has a Grade >-2 corneal epithelial condition.
- •Has any active renal condition
- •Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening.
- •Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to <-Grade 1 or to the baseline status preceding prior therapy.
- •Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis.
- •Has a lung-specific intercurrent clinically significant illness
- •Has FEV1 <50% predicted
- •Has chronic enteritis or inflammatory bowel disease or any history of clinically significant bleeding of gastrointestinal tract or clinically significant obstruction and/or perforation and/or fistulae of GI tract.
- •Has a known hypersensitivity to any component of GSK5533524 or its excipients.
- •Has history of severe allergies, or severe infusion related reactions, or idiosyncrasy to recombinant humanized proteins.
- •Has received any MUC16 targeted therapies.
- •Has received prior therapy with TOPO1i or TOPO1i ADCs.
- •Has received any cytotoxic chemotherapy drugs, or other anti-tumor drugs within 28 days prior to the first dose of study drug.
- •Has 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 intervention.
- •Has received immunosuppressive agents or required long-term glucocorticoid therapy within 30 days prior to first dose of study treatment.
- •Has corrected QT interval by Fridericia formula (QTcF) >450 msec or QTcF >480 msec for participants with bundle branch block.
- •Has a left ventricular ejection fraction (LVEF) < 50%.
研究者
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