JPRN-jRCT2080223999招募中1 期
A phase Ia/Ib, open label, multicenter, dose-escalation study of BI 907828 in patients with advanced or metastatic solid tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Pathologically documented, advanced solid tumors.
- •2. Patients fulfilling one or more of the following criteria:
- •a. Radiologically documented disease progression or relapse
- •b. Patients who are not eligible to receive standard of care treatments, and for whom no proven treatments exist.
- •c. Patients with MDM2 amplified sarcomas who require first line treatment (for Ph Ib/dose expansion - Cohort 1 only).
- •Patients with MDM2 amplified sarcomas may fulfil any one of the above three criteria to be considered eligible.
- •3. a. Phase Ia (dose escalation) only:Patient has a tumor with either a known TP53 wild type status, or unknown TP53 status, and regardless of MDM2 amplification status, at the time of study entry.
- •b. Phase Ib (expansion phase) only:
- •- Cohort 1: TP53 wt and MDM2-amplified sarcoma with advanced/metastatic disease at any line of therapy. If TP53 status is not available during screening, the patient may be included with unknown TP53 status if a tissue sample is submitted for central laboratory assessment. If TP53 status cannot be evaluated, the patient may be included if agreed between the Investigator and Sponsor.
- •- Cohort 2: TP53 wt and MDM2- amplified NSCLC, urothelial, gastric, biliary tract (including cholangiocarcinoma, intra- and extrahepatic biliary tree, gall blander and ampulla of vater) or pancreatic solidPDAC tumors who have had at least one previous line of therapy for advanced/metastatic disease. If TP53 status cannot be evaluated the patient may be included if agreed between the Investigator and Sponsor
排除标准
- •1. Known TP53 mutant tumor.
- •2. Previous administration of BI 907828 or any other MDM2-p53 or MDMX (MDM4)-p53 antagonist.
- •3. Symptomatic brain metastases from non-brain tumors. Note: Patients with previously treated brain metastases may participate but treated brain lesion could not be used as target lesion.
- •4. Patients with history of bleeding diathesis.
研究者
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