癌研連線CancerLink
已完成 NCT04526106

REFOCUS：高度選擇性 FGFR2 抑制劑 RLY-4008 於 ICC 及其他晚期實體瘤患者中的首次人體研究

膽道癌Phase IIII 期IV 期

這是一項第一期/第二期、開放標籤、首次人體（FIH）研究，旨在評估 RLY-4008（一種強效且高度選擇性的 FGFR2 抑制劑）在不可切除或轉移性膽管癌（CCA）及其他實體瘤患者中的安全性、耐受性、藥物動力學（PK）、藥效學（PDy）及抗腫瘤活性。本研究包括 4 個部分：劑量遞增（第 1 部分）、劑量擴展（第 2 部分）、延伸（第 3 部分）及滾動（第 4 部分）。

適應症：FGFR2 Amplification、FGFR2 Gene Mutation、FGFR2 Gene Fusion/Rearrangement、FGFR2 Gene Translocation、FGFR2 Gene Activation、Intrahepatic Cholangiocarcinoma、Cholangiocarcinoma、Other Solid Tumors, Adult

收案條件

納入條件

  • Histologically or cytologically confirmed unresectable or metastatic solid tumor
  • Documented FGFR2 gene fusion, mutation, or amplification per local testing of blood and/or tumor
  • Patient must have measurable disease per RECIST v1.1
  • Patient has ECOG performance status of 0-1
  • Patient must have disease that is refractory to standard therapy, disease that has not adequately responded to standard therapy, disease for which standard or curative therapy does not exist, or the patient must be intolerant to or have declined standard therapy
  • Part 2 dose expansion patients with Cholangiocarcinoma:
  • Group 1: CCA patients with an FGFR2 fusion previously treated with an FGFRi
  • Group 2: CCA patients with an FGFR2 fusion with prior chemotherapy but not previously treated with an FGFRi
  • Group 6: CCA patients with an FGFR2 fusion with no prior chemotherapy and not previously treated with an FGFRi. Prior adjuvant/neo-adjuvant treatment completed \>6 months before enrollment is acceptable. Up to 2 cycles of palliative chemotherapy are allowed during screening
  • Group 7: CCA patients with an FGFR2 mutation or amplification and not previously treated with an FGFRi. Note: For Group 7, patients with confirmed diagnosis of unresectable or metastatic CCA with an FGFR2 fusion are not eligible.
  • Part 2 dose expansion patients with other solid tumors (NOT Cholangiocarcinoma):
  • Group 3: Non-CCA patients with an FGFR2 fusion and not previously treated with an FGFRi.
  • Group 4: Non-CCA patients with an FGFR2 amplification and not previously treated with an FGFRi.
  • Group 5: Non-CCA patients with an FGFR2 mutation and not previously treated with an FGFRi
  • Part 3 extension:
  • o CCA patients with an FGFR2 fusion with prior chemotherapy but not previously treated with an FGFRi
  • Part 4:
  • Patient is receiving RLY-4008 on RLY-4008-101 study and benefiting from treatment as assessed by the investigator.

排除條件

  • Parts 1, 2, and 3
  • Ongoing, clinically significant FGFRi-induced retinal detachment or an ongoing clinically significant corneal or retinal disorder
  • Patient does not have adequate organ function (defined in protocol)
  • Patient has active infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) (defined in protocol). Patients with well-controlled HBV are eligible (defined in protocol).
  • QT interval corrected using Fridericia\'s formula (QTcF) \> 480 msec or history of prolonged QT syndrome, Torsades de pointes or familial history of prolonged QT syndrome
  • Clinically significant, uncontrolled cardiovascular disease
  • CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms
  • Part 4:
  • Patient has permanently discontinued treatment with RLY-4008 for any reason before enrolling into Part 4.

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。