这项临床试验是一项第一期／第二期、开放标签、序贯组别、剂量递增及队列扩展研究，旨在确定 FLX475 作为单药治疗及联合 pembrolizumab 的安全性及初步抗肿瘤活性。 研究将分为两部分进行：剂量递增阶段（第一部分）及队列扩展阶段（第二部分）。
适应症：Advanced Cancer
入组条件
纳入标准
- Documented advanced or metastatic cancer ineligible for standard therapies with one of the following histologies
- Dose Escalation: non-small cell lung cancer, head and neck squamous cell carcinoma, nasopharyngeal carcinoma, metastatic triple negative breast cancer, urothelial carcinoma, gastric cancer, esophageal carcinoma, cervical cancer, classical Hodgkin lymphoma
- Dose Expansion: nasopharyngeal carcinoma, lymphoma, head and neck squamous cell carcinoma, cervical cancer, non-small cell lung cancer, triple-negative breast cancer
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Evaluable disease at baseline (at least one measurable target lesion by imaging for expansion cohorts)
- Tumor available for biopsy
排除标准
- History of allergy or severe hypersensitivity to biologic agents
- History of Grade 3-4 immune-related adverse events leading to discontinuation of prior immuno-oncology treatment
- Active autoimmune disease or serious autoimmune disease within past 2 years requiring systemic therapy
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, (non-infectious) pneumonitis that required steroids, or symptoms of active pneumonitis
- Prior allogeneic hematopoietic stem cell transplant within 5 years, or prior allogeneic organ transplant
- Active graft-versus-host disease
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。