本研究旨在评估futibatinib在3个不同队列的FGFR异常患者中的疗效与安全性。患者将被纳入3个队列之一：携带FGFR1-4重排的晚期、转移性或局部晚期实体瘤患者（不包括原发性脑肿瘤及肝内胆管癌[iCCA]）；
适应症：Advanced or Metastatic Solid Tumor、Advanced or Metastatic Gastric or Gastroesophageal Cancer、Myeloid or Lymphoid Neoplasms (MLN)
入组条件
纳入标准
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Known FGFR aberration status and tumor type that meet all of the criteria for 1 of the following cohorts:
- a. Cohort A
- i. Histologically-confirmed, locally-advanced, advanced, or metastatic solid tumors harboring a FGFR1-4
- ii. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- iii. Had disease progression/recurrence after standard treatment for their cancer
- b. Cohort B
- i. Histologically-confirmed, locally-advanced, advanced, or metastatic gastric or gastroesophageal junction cancer harboring a FGFR2 amplification.
- ii. Measurable disease per RECIST 1.1
- iii. Received at least 2 prior systemic regimens for advanced/metastatic disease
- iv. Experienced disease progression/recurrence during or after the most recent prior systemic treatment for advanced/metastatic gastric cancer or GEJ cancer
- c. Cohort C
- i. Confirmed myeloid or lymphoid neoplasms as defined by WHO criteria with a FGFR1 rearrangement
- ii. Not a candidate for hematological stem cell transplant (HSCT) or relapsed after HSCT and donor lymphocyte infusion, and progressed and not a candidate for other therapies
排除标准
- History and/or current evidence of any of the following disorders:
- Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator
- Ectopic mineralization/calcification including, but not limited to, soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the Investigator
- Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant in the opinion of the Investigator.
- Prior treatment with an FGFR inhibitor
- Brain metastases that are untreated or clinically or radiologically unstable (that is, have been stable for \<1 month)
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。