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

  • End date
    Oct 14, 2024
  • participants needed
  • sponsor
    Relay Therapeutics, Inc.
Updated on 14 September 2023
measurable disease
growth factor
solid tumors
cancer chemotherapy
antineoplastic agents
solid tumour
solid tumor
advanced solid tumor
growth factors
intrahepatic bile duct carcinoma
fgfr inhibitor


This is a Phase 1/2, open-label, FIH study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDy), and antineoplastic activity of RLY-4008, a potent and highly selective FGFR2 inhibitor, in patients with unresectable or metastatic cholangiocarcinoma (CCA) and other solid tumors. The study consists of 3 parts: a dose escalation (Part 1), a dose expansion (Part 2), and an extension (Part 3).

Condition FGFR2 Amplification, FGFR2 Gene Mutation, FGFR2 Gene Fusion/Rearrangement, FGFR2 Gene Translocation, FGFR2 Gene Activation, Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma, Other Solid Tumors, Adult
Treatment RLY-4008
Clinical Study IdentifierNCT04526106
SponsorRelay Therapeutics, Inc.
Last Modified on14 September 2023


Yes No Not Sure

Inclusion Criteria

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 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
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
Patient has ECOG performance status of 0-1
CCA patients with an FGFR2 fusion with prior chemotherapy but not previously treated with an FGFRi

Exclusion Criteria

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
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