CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 490 enrolled
Drug / intervention
RLY-4008drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04526106
NCT04526106Phase 2Completed
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A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors

Elevar Therapeutics·interventional·Posted Aug 25, 2020·Updated Feb 27, 2026

In Brief

A Phase 2 clinical trial evaluating RLY-4008 for FGFR2 Amplification and 7 related conditions. Completed, enrolled 490 participants across 48 sites in 13 countries.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFGFR2 Amplification, FGFR2 Gene Mutation, FGFR2 Gene Fusion/Rearrangement, FGFR2 Gene Translocation, FGFR2 Gene Activation, Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma, Other Solid Tumors, Adult
CountriesAustralia, France, Germany, Hong Kong, Italy, Netherlands, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedAug 25, 2020
Enrollment StartSep 2, 2020
Primary CompletionSep 5, 2025
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 5.9 years ago

Interventions

RLY-4008drug

RLY-4008 is an oral inhibitor of FGFR2