jRCT2080224717已完成1 期
A Phase 1a / 1b, First-in-human, Open-label,Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0903 Administered Daily for 21 Days to Patients with Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- A Phase 1a / 1b, Open-label, Dose-escalation, Safety, Pharmacokinetics, And Pharmacodynamic (pd) Study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients with unresectable advanced solid tumors who have shown disease progression after receiving standard/ approved chemotherapy
- •Patients with unresectable advanced solid tumors and one of the following tumor types:
- •a. Have progressed after IO therapy and are felt to be appropriate for this type of treatment
- •b. Have EGFR+ NSCLC and have demonstrated recent progression on <=2 lines of oral TKIs and are felt to be appropriate for this type of treatment.
- •c. Have BRAF-, KRAS-, or NRAS-mutated CRC, have received no more than 3 previous lines of treatment, and for whom there is no standard therapy remaining
- •d. Have persistent/recurrent ovarian cancer who would be platinum refractory/ resistant and have had any number of lines of prior therapy
- •e. Have BRAF-mutated or BRAF wild-type melanoma that has progressed following IO therapy or a combination BRAF/MEK inhibitor therapy
排除标准
- •Severe heart disease, lung disease, or seizure disease that require treatment with antiepileptic drugs
- •Major surgery or radiation therapy within 2 weeks prior to the start date
- •Significant surgery to the gastrointestinal tract that could impair absorption
- •Pregnant or nursing
结局指标
主要结局
-
safety To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs)
次要结局
- pharmacokinetics
- antitumor activity
- Recommended Phase 2 Dose (RP2D)
研究者
研究点 (1)
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