A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients With Solid Tumors Likely to Express NaPi2b
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- DES and EXP: Safety and Tolerability
研究概览
简要总结
First-in-human, Phase 1b/2 safety study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks. Patients with tumor types likely to express NaPi2b were enrolled in dose escalation. Patients with platinum-resistant ovarian cancer and non-small cell lung cancer (adenocarcinoma subtype) were enrolled in the expansion segment of this study. In addition to safety assessments, the pharmacokinetics of the drug were assessed along with ADC activity.
详细描述
This is a multi-center study of XMT-1536 (upifitamab rilsodotin) in patients with tumors likely to express NaPi2b, focusing on patients with platinum-resistant ovarian cancer and non-small cell lung cancer, adenocarcinoma subtype. XMT-1536 (upifitamab rilsodotin) was administered as an intravenous infusion once every four weeks. The DES segment studied small groups of patients who received increased doses. A Safety Review Committee was established to review the data from each dose level before moving to the next higher dose. The dose escalation cohort has ended and is no longer enrolling patients. All adverse events were graded according to the National Cancer Institute (NCI) Common Terminology Criteria version (CTCAE v5.0). Throughout the study, pharmacokinetics were measured using proprietary assays developed by Mersana. Anti-cancer activity were measured via RECIST.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose Escalation
XMT-1536 (upifitamab rilsodotin) treatment is administered in groups of patients who will receive doses that increase over time.
This cohort is closed to enrollment.
干预措施: upifitamab rilsodotin (Drug)
结局指标
主要结局
DES and EXP: Safety and Tolerability
时间窗: First dose up until 30 days after study termination
Evaluate incidence and severity of adverse events
DES: Maximum tolerated dose or recommended Phase 2 dose
时间窗: Up to 36 weeks, from the date of first dose until unacceptable side effects or a dose-limiting toxicity is met
Evaluate adverse events and concomitant medication use after XMT-1536 (upifitamab rilsodotin) doses
次要结局
- DES: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin)(Every 6 weeks for up to 36 weeks)