REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors

Exclusion Criteria

• •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
• •* 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.