A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512622-29-00

Acronym

RLY-4008-101

Enrollment

159

Registered

2024-09-04

Start date

2021-09-10

Completion date

2025-08-20

Last updated

2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma (CCA) and Other Advanced Solid Tumors

Brief summary

Part 1: MTD and RP2D of RLY-4008, Part 1: Overall safety profile of RLY-4008, Parts 2 & 3: Objective response rate (ORR) assessed by Independent Review Committee (IRC) using RECIST v.1.1, Part 4: Frequency, severity, timing, and relationship to RLY-4008 of any AEs and SAEs. Dose modifications.

Detailed description

Part 1: FGFR2 genotype in blood and tumor tissue, Part 1: PK parameters of RLY-4008 (and its metabolites if appropriate) including, but not limited to Maximum Concentration (Cmax), Time to Maximum Concentration (Tmax), Area Under the concentration-Time Curve (AUC), effective half-life(T1/2eff), clearance (CL/F), and other relevant parameters, Part 1: Pharmacodynamic parameters: including, but not limited to blood markers, Part 1: Overall response rate (ORR), Duration of Response (DOR), and Disease Control Rate (DCR) per RECIST 1.1, Parts 2 & 3: Duration of response (DOR) by Independent Review Committee (IRC) using RECIST v.1.1

Interventions

DRUGRLY-4008

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1: MTD and RP2D of RLY-4008, Part 1: Overall safety profile of RLY-4008, Parts 2 & 3: Objective response rate (ORR) assessed by Independent Review Committee (IRC) using RECIST v.1.1, Part 4: Frequency, severity, timing, and relationship to RLY-4008 of any AEs and SAEs. Dose modifications.	—

Secondary

Measure	Time frame
Part 1: FGFR2 genotype in blood and tumor tissue, Part 1: PK parameters of RLY-4008 (and its metabolites if appropriate) including, but not limited to Maximum Concentration (Cmax), Time to Maximum Concentration (Tmax), Area Under the concentration-Time Curve (AUC), effective half-life(T1/2eff), clearance (CL/F), and other relevant parameters, Part 1: Pharmacodynamic parameters: including, but not limited to blood markers, Part 1: Overall response rate (ORR), Duration of Response (DOR), and Disease Control Rate (DCR) per RECIST 1.1, Parts 2 & 3: Duration of response (DOR) by Independent Review Committee (IRC) using RECIST v.1.1	—

Measure

Time frame

—

Countries

France, Germany, Netherlands, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026