一分钟看懂
这是一项关于前列腺癌的I 期 / II 期研究,登记的药物或干预包括FOR46;Enzalutamide;Pegfilgrastim;Blood Samples,当前状态为研究进行中,已停止招募。登记地点显示中国San Francisco有研究中心记录。是否仍有名额以及是否值得进一步询问,需要向研究中心确认。
药物或干预
FOR46;Enzalutamide;Pegfilgrastim;Blood Samples · I 期 / II 期
中国哪些地方有记录
以下地点来自登记信息,不代表此刻仍有名额;请向研究中心确认最新情况。
- University of California, San Francisco · San Francisco
公开的入选条件
- 1. Histologically confirmed metastatic prostate adenocarcinoma.
- 2. Disease progression by PCWG3 criteria at study entry.
- 3. Prior progression by PCWG3 criteria on one or more androgen signaling inhibitors including abiraterone acetate, enzalutamide, apalutamide, and/or darolutamide.
- 4. No prior taxane-based chemotherapy for the treatment of mCRPC. Prior taxane use in the castration-sensitive prostate cancer (CSPC) setting allowed provided last dose \> 6 months prior to study entry.
- 5. Patients must be evaluable for the primary endpoint of composite response, and must have either serum PSA ≥ 2 ng/mL during Screening and/or measurable disease by RECIST 1.1 criteria.
- 6. Participants must be willing to undergo metastatic tumor biopsy during Screening. If there is no safely accessible metastatic lesion, this requirement will be waived.
- 7. Dose Expansion only: Participants must be willing to undergo CD46-directed Positron Emission Tomography (PET) imaging during Screening (Co-enrolling on NCT05245006, Groups B and C)
- 8. Castrate level of serum testosterone at study entry (\<50 ng/dL). Patients without prior bilateral orchiectomy are required to remain on Luteinizing hormone-releasing hormone (LHRH) analogue treatment for duration of study.
联系前需要确认
请继续确认中心是否启动、疾病分型、既往治疗、检查费用和知情同意安排。
查看登记信息
登记号:NCT05011188;登记信息更新于 2026-09-17。