JPRN-jRCT2031220470进行中（未招募）1 期
An Open-Label Phase 1 Study of MEDI5752 in Japanese Patients with Advanced Solid tumors
Hibi Kazushige0 个研究点目标入组 18 人开始时间: 2022年11月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Age or more 18 years at the time of screening
- •2. World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
- •3. Life expectancy is 12 weeks or more.
- •4. Histologically or cytologically-confirmed advanced solid tumors
- •5. Subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy or any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment may be eligible to enter the study following a washout period as applicable
- •6. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception
- •7. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a male condom where locally available from Day 1 and for 90 days after the final dose of investigational product.
- •8. Subjects must have at least one measurable lesion
- •9. Adequate organ and marrow function
- •10. Signed and dated written informed consent
- •11. Subjects must provide tumor material as applicable
排除标准
- •1. Involvement in the planning and/or conduct of the study (applies to both MedImmune staff and/or staff at the study site)
- •2. Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
- •3. For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4:
- •a. Subjects must not have received anti-PD-1, anti-PD-L1, anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 21 days of commencing treatment with investigational product.
- •b.Subject must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
- •c.All AEs while receiving prior immunotherapy must have completely resolved or resolved to Grade 1 prior to screening for this study.
- •4. Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product is excluded.
- •5. Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product.
- •6. Active or prior documented autoimmune or inflammatory disorders
- •7. History of organ transplant
- •8. Known allergy or reaction to any component of the planned study treatment.
- •9. Untreated CNS metastatic disease, leptomeningeal disease, or cord compression
- •10. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria
- •11. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of Investigational Product or still recovering from prior surgery
- •12. Female subjects who are pregnant or breastfeeding, as well as male or female subjects of reproductive potential who are not willing to employ one highly effective method of birth control
- •13. Uncontrolled intercurrent illness, that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent.
- •14. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of the subject's safety or study results
- •15. Judgment by the investigator that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions, and requirements.
研究者
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