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RLY-4008

DRUG2 trials

Sponsors

Elevar Therapeutics Inc., Elevar Therapeutics

Conditions

CholangiocarcinomaCholangiocarcinoma (CCA) and Other Advanced Solid TumorsFGFR2 AmplificationFGFR2 Gene ActivationFGFR2 Gene Fusion/RearrangementFGFR2 Gene MutationFGFR2 Gene TranslocationIntrahepatic Cholangiocarcinoma

Phase 1

REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors
CompletedNCT04526106
Elevar TherapeuticsCholangiocarcinoma, FGFR2 Amplification, FGFR2 Gene Activation +5
Start: 2020-09-02End: 2025-09-05Updated: 2026-02-27
A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors
CompletedCTIS2024-512622-29-00
Elevar Therapeutics Inc.Cholangiocarcinoma (CCA) and Other Advanced Solid Tumors
Start: 2021-09-10End: 2025-08-20Target: 159Updated: 2025-09-03

Related Papers

Data from Recurrent Resistance Mutations to Lirafugratinib Inform Treatment Sequencing in <i>FGFR2</i>-Driven Tumors
2026-06-17
A phase 2, open-label, single-arm study of lirafugratinib in patients with previously treated, unresectable, locally advanced, or metastatic solid tumors (excluding cholangiocarcinoma) with <i>FGFR2</i> fusion or rearrangement.
Journal of Clinical Oncology2026-05-28
Recurrent resistance mutations to lirafugratinib inform treatment sequencing in FGFR2-driven tumors
Clinical Cancer Research2026-02-03
Mechanisms of Clinical Resistance to Selective FGFR2 Inhibition by Lirafugratinib.
2026-01-20
Efficacy and safety of lirafugratinib in <i>FGFRi</i> -naïve cholangiocarcinoma (CCA) patients harboring <i>FGFR2</i> fusions/rearrangements ( <i>FGFR2</i> f/r).
Journal of Clinical Oncology2026-01-10
A Phase I Study of KIN-3248, an Irreversible Small-molecule Pan-FGFR Inhibitor, in Patients with Advanced FGFR2/3-driven Solid Tumors
Cancer Research Communications2024-04-1116 citations
Abstract IA006: Clinical activity of lirafugratinib (RLY-4008), a highly selective FGFR2 inhibitor, in patients with advanced FGFR2-altered solid tumors: The ReFocus study
Molecular Cancer Therapeutics2023-12-019 citations
Updated dose escalation results for ReFocus, a first-in-human study of highly selective FGFR2 inhibitor RLY-4008 in cholangiocarcinoma and other solid tumors.
Journal of Clinical Oncology2023-06-0135 citations
Abstract OT3-24-01: ReFocus: A Phase 1/2 Study of the Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients with Advanced Solid Tumors Including Breast Cancer
Cancer Research2023-03-01
Abstract P02-02: First results of RLY-4008, a potent and highly selective FGFR2 inhibitor in a first-in-human study in patients with FGFR2-altered cholangiocarcinoma and multiple solid tumors
Molecular Cancer Therapeutics2021-12-0111 citations
First-in-human study of highly selective FGFR2 inhibitor, RLY-4008, in patients with intrahepatic cholangiocarcinoma and other advanced solid tumors.
Journal of Clinical Oncology2021-05-2014 citations