NL-OMON53228尚未招募不适用
Clinical Performance Study Plan for use of B7-H4 (A57.1) Clinical Trial Assay for Patient Enrolment Into The Clinical study (D6900C00001), titled *A Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants with Advanced or Metastatic Solid Malignancies*. - AZD8205 in participants with metastatic solid malignancies
Astra Zeneca0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
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
- 18 至 99（—）
入选标准
- •Eastern Cooperative Oncology Group PS 0-1.
- •Participants with relapsed/metastatic solid tumors (biliary tract cancer,
- •ovarium cancer, breast cancer or endometrial cancer) must have received prior
- •adequate SoC therapy for their tumor type and stage of disease
- •Participants must have measurable disease per RECIST v1.1
- •Life expectancy >= 12 weeks
- •Adequate organ function
- •The respective cohorts for patient inclusion are:
- •- Cohort 1: Biliary tract cancer
- •- Cohort 2: Ovarian cancer
- •- Cohort 3: Breast cancer
- •- Cohort 4: Endometrial cancer
排除标准
- •Participants with spinal cord compression or a history of leptomeningeal
- •carcinomatosis
- •Participants with brain metastases unless treated, asymptomatic, stable
- •Unresolved toxicities of Grade >= 2 (NCI CTCAE v5.0) from prior therapy
- •Active infection, including tuberculosis and infections with HBV, HCV or HIV
- •Has a history of (non-infectious) ILD/pneumonitis that required steroids, has
- •ILD/pneumonitis
- •Clinically severe pulmonary compromise resulting from intercurrent pulmonary
- •History of another primary malignancy
- •Participants with History of arrhythmia, Uncontrolled hypertension, Acute
- •coronary syndrome/acute myocardial infarction, unstable angina pectoris and
- •other heart diseases
- •Uncontrolled intercurrent illness
研究者
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