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REFOCUS: A First-in-Human Stu...

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

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

490 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-02

Study Completion Date

2027-12-31

Brief Summary

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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 4 parts: a dose escalation (Part 1), a dose expansion (Part 2), and an extension (Part 3) and a rollover (Part 4).

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Part 1 (multiple ascending doses):

• Unresectable or metastatic CCA or other unresectable or metastatic solid tumor

Part 2 (RP2D determined in Part 1):

* Group 1: CCA patients w/ an FGFR2 fusion previously treated w/ an FGFRi treatment
* Group 2: CCA patients w/ an FGFR2 fusion w/ prior chemotherapy but no prior FGFRi treatment
* Group 3: Non-CCA patients w/ an FGFR2 fusion and no prior FGFRi
* Group 4: Non-CCA patients w/ an FGFR2 amplification and no prior FGFRi treatment
* Group 5: Non-CCA patients w/ an FGFR2 mutation and no prior FGFRi treatment
* Group 6: CCA patients w/ an FGFR2 fusion with no prior chemotherapy and no prior FGFRi treatment
* Group 7: CCA patients w/ an FGFR2 mutation or amplification and no prior FGFRi treatment

Part 3 (Extension of Part 2, Group 2):

• CCA patients w/ an FGFR2 fusion with prior chemotherapy but no prior FGFRi treatment

Part 4 (Rollover):

• Ongoing Parts 1, 2, and 3 patients enrolled on study and receiving RLY-4008

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: Dose Escalation

Multiple doses of RLY-4008 for oral administration.

Group Type EXPERIMENTAL