NCT04526106CompletedPhase 1/2
First-in-Human Study of RLY-4008 in Patients With ICC and Other Advanced Solid Tumors
A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors
Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Sept 2025
Brief summary (registry, in English)
Part 1 • To determine the MTD and RP2D of RLY-4008 • To determine the safety and tolerability of RLY-4008 Part 2 and 3 • To evaluate the efficacy of RLY-4008 by objective response rate (ORR) assessed by Independent Review Committee (IRC) Part 4 • To assess the safety and tolerability of RLY-4008
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 159 (actual)
- First submitted
- 8 Aug 2024
- Start date
- 10 Sept 2021
- Lead sponsor
- Elevar Therapeutics Inc.
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04526106
- EU CT number
- 2024-512622-29-00
- EudraCT number
- 2020-004535-24
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 159
- 15 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other
- Main exclusion criteria for the study, including specific criteria for Part 1, 2, 3 and 4 can be found in the study protocol (section 5.3).
Who the study is looking for
- Main inclusion criteria for the study, including specific criteria for Part 1, 2, 3 and 4 can be found in the study protocol (section 5.2).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Completed |
| National Center for Tumor Diseases (NCT) Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Completed |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Completed |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Completed |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Completed |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Completed |
| NKI Coordinator of this site? Confirm its status | Amesterdam | Netherlands | Completed |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Completed |
Related publications
- Mechanisms of clinical resistance to selective FGFR2 inhibition by lirafugratinib.Ann Oncol · 2026 · PMID 41571046
This page is information, not medical advice. Discuss any trial with your doctor.