Clinical trial · no report yet · Phase 1/Phase 2
NCT04526106
REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors
- NCT04526106 ↗
- Completed
- Elevar Therapeutics
- 21 commentary sources found
- Standard
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.
| Channel | Found | |
|---|---|---|
| X threads | 21 |
The trial
ClinicalTrials.gov- Official title
- A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors
- Phase
- Phase 1/Phase 2
- Status
- Completed
- Conditions
- FGFR2 Amplification; FGFR2 Gene Mutation; FGFR2 Gene Fusion/Rearrangement; FGFR2 Gene Translocation; FGFR2 Gene Activation; Intrahepatic Cholangiocarcinoma; Cholangiocarcinoma; Other Solid Tumors, Adult
- Interventions
- RLY-4008
- Arms
- Part 1: Dose Escalation · Experimental
- Part 2: Dose Expansion · Experimental
- Part 3: Extension · Experimental
- Part 4: Rollover · Experimental
- Enrollment
- 490
- Primary outcomes
- Part 1 and Part 4: Number of patients with adverse events and serious adverse events
- Part 1: Determination of maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RLY-4008
- Part 2 and Part 3: Objective Response Rate (ORR) assessed by Independent Review Committee per RECIST v1.1
- Part 4: Number of patients with dose interruptions
- Part 4: Number of patients with dose reductions
- Part 4: Number of patients with dose discontinuations
- Sponsor
- Elevar Therapeutics
- Start
- Sep 2, 2020
- Primary completion
- Sep 5, 2025
- Results posted
- No
- Registry record
- NCT04526106 · updated Feb 27, 2026
Publications
linked from the registry- Ellis H, Balasooriya ER, Varkaris A, Hajian B, Wan J, Shekhar M, Gritti I, Vijay V, Albertelli L, Piot S, Lau K, Kehlmann A, Chevalier N, Nugent FW, Zhen Y, Silveira VS, Sellers WR, Corcoran RB, Juric D, Bardeesy N. Mechanisms of clinical resistance to selective FGFR2 inhibition by lirafugratinib. Ann Oncol. 2026 Jun;37(6):798-812. doi: 10.1016/j.annonc.2026.01.004. Epub 2026 Jan 20. PubMed 41571046