FGFR3-selective inhibitor ยท small molecule

TYRA-300

2 active trials, targeting FGFR3. Not approved for any biomarker on marked.bio yet.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
FGFR3 alteration (mutation or fusion) 2 2 Phase 2

Sponsors

Industry sponsors leading active biomarker-selected trials of TYRA-300.

  1. Tyra Biosciences 2

Trials

Status

2 of 2 trials shown

  1. Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer

    Recruiting Phase 2 Tyra Biosciences Started 2025Primary completion 2028-02 NCT06995677

    TYRA-300

    Documented activating FGFR3 alteration (mutation or fusion)

    FGFR3 alteration (mutation or fusion)Low-grade NMIBC, FGFR Gene Amplification, FGFR Gene Alterations, FGFR3 Gene Alteration

  2. Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations

    Active, not recruiting Phase 1/2 Tyra Biosciences Started 2022Primary completion 2026-11 NCT05544552

    TYRA-300

    Histologically confirmed advanced solid tumor with an eligible FGFR3 gene mutation or fusion (Part B).

    FGFR3 alteration (mutation or fusion)Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Solid Tumor, Urothelial Carcinoma