Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Elevar Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
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
