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Single arm trial of RLY-4008 in pan-FGFR (FGFRi) treatment-naïve FGFR2-fusion cholangiocarcinoma (CCA)

Trial Profile

Single arm trial of RLY-4008 in pan-FGFR (FGFRi) treatment-naïve FGFR2-fusion cholangiocarcinoma (CCA)

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 06 Dec 2024

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At a glance

  • Drugs Lirafugratinib (Primary)
  • Indications Cholangiocarcinoma
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 03 Dec 2024 According to a Relay Therapeutics media release, Elevar will be granted global development and commercialization rights for lirafugratinib and will assume full responsibility for all further development activities, including submission of the NDAs, all subsequent clinical development, and global commercialization for FGFR2-driven CCA and FGFR2-altered other solid tumors.
  • 11 Aug 2022 New trial record
  • 04 Aug 2022 According to a Relay Therapeutics media release, based on discussions with the U.S. Food and Drug Administration (FDA), alignment on the design of this trial will potentially support an accelerated approval path.

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