jRCT2031250860招募中不适用
A Multicenter, Open-Label, Phase 1a/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C477 in Patients with Selected Advanced Solid Tumors
未提供0 个研究点目标入组 18 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
- 分配方式
- Non Randomized
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participants must sign the informed consent form (ICF) and be capable of giving written informed consent
- •Participants must consent to provide an archival tumor tissue sample or a fresh baseline biopsy
- •Phase 1a (Dose Escalation); Histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, who were previously treated with at least 2 lines of standard systemic therapy or for whom no standard treatment is available in the medical judgment of the investigator
- •Phase 1b (Dose Expansion) Part A: Histologically confirmed advanced or metastatic select solid tumors that were previously treated with and progressed from at least 1 line of standard systemic therapy
- •Phase 1b (Dose Expansion) Part B: Histologically confirmed advanced or metastatic select solid tumors who have previously received 0 or 1 line of systemic therapy for advanced disease
- •>_ 1 measurable lesion as assessed by RECIST v1.1
- •Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of <_ 1
- •Adequate organ function
- •Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for >_ 8 months after the last dose of BG-C477, for >_ 6 months after the last dose of chemotherapy, and for >_ 4 months after the last dose of tislelizumab,whichever comes later
- •Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for >_ 5 months after the last dose of BG-C477, for >_ 3 months after chemotherapy, and for >_ 4 months after the last dose of tislelizumab, whichever comes later.
排除标准
- •Prior treatment with any carcinoembryonic antigen (CEA)-targeted ADCs or ADCs containing topoisomerase 1 (TOP1) inhibitor as payload
- •History of severe allergic reactions, severe reaction to infusion, or hypersensitivity to the active ingredient and excipients of the study drug(s) or protein-based therapeutics
- •Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- •Any malignancy <_ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
研究者
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