This is a single-arm, open-label, multicenter, investigator-initiated Phase 2 trial to evaluate the efficacy and safety of E7090 in patients with advanced or recurrent solid tumors harboring FGFR genetic alterations (including fusion, mutation, amplification).
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Participants with histologically or cytologically confirmed metastatic, unresectable, or recurrent solid tumor who agree to provide an archival tumor sample, a residual biopsy sample, or a fresh tumor biopsy sample
✓. Ineffective to or intolerant to initial treatment, or for which standard treatment is no longer available
✓. Participants with an FGFR gene alteration detected by NGS panel, who fall under one of the categories of groups A to C and E defined as below
✓. For Group D, participants with cholangiocarcinoma who have previously received a selective FGFR inhibitor other than E7090 and have demonstrated progressive disease or resistance
✓. Karnofsky Performance Status (KPS) \>= 70 for patients with primary CNS tumors. Performance Status (ECOG) 0-1 for patients with non-primary CNS tumors
✓. For patients with non-primary CNS tumors, they have at least 1 lesion of \>= 10 millimeter (mm) in the longest diameter for a non-lymph node or \>= 15 mm in the short-axis diameter for a lymph node that is considered as serially measurable according to RECIST v1.1 using computerized tomography or magnetic resonance imaging (CT or MRI) within 28 days of enrollment. However, lesions that have received local treatment such as external-beam radiation therapy (EBRT) or radiofrequency ablation (RFA) must have progressed after these local treatment to count as measurable lesion
✓. Participants with primary CNS tumors must meet all of the following criteria:
✓. Have received prior treatment including radiation and/or chemotherapy, as recommended or appropriate for the CNS tumor type
✕. Participants with brain, subdural or leptomeningeal metastases
✕. Participants with primary CNS tumor located in either cerebellum, brainstem, spinal cord, pituitary gland, optic nerve or olfactory nerve
✕. Positive for either human immunodeficiency virus (HIV) antibody, HBs antigen, or HCV antibody (patients with positive HCV antibody but no detectable HCV-RNA are not excluded)
✕. Negative for HBs antigen, but positive for HBs antibody or HBc antibody, and also positive for HBV-DNA quantification (not excluded if HBV-DNA is below detection sensitivity)
✕. Child-Pugh score B or C
✕. Participants with pericardial effusion, pleural effusion, or ascites requiring treatment