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Evaluating TYRA-300 for advanced urothelial carcinoma and other solid tumors with FGFR3 gene alterations

A Multicenter, Open-label Phase 1/2 Study of TYRA300 in Advanced Urothelial Carcinoma and Other Solid Tumors With Activating FGFR3 Gene Alterations (SURF301)

Phase1; Phase2 Interventional Tyra Biosciences, Inc · NCT05544552

This study is testing a new drug called TYRA-300 to see if it can help people with advanced bladder cancer and other solid tumors that have specific gene changes.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment310 (estimated)
Ages18 Years and up
SexAll
SponsorTyra Biosciences, Inc Industry-sponsored
Locations21 sites (Ocala, Florida and 20 other locations)
Trial IDNCT05544552 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of TYRA-300, a selective FGFR3 tyrosine kinase inhibitor, in patients with advanced urothelial carcinoma and other solid tumors that have FGFR3 gene alterations. The study is divided into two phases: Phase 1 focuses on determining the optimal and maximum tolerated doses of TYRA-300, while Phase 2 assesses its preliminary effectiveness in treating these cancers. Participants will be monitored for their response to the treatment and any side effects experienced during the trial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors that have FGFR3 gene mutations or rearrangements and have exhausted standard treatment options.

Not a fit: Patients without FGFR3 gene alterations or those with early-stage tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced urothelial carcinoma and other solid tumors harboring FGFR3 alterations.

How similar studies have performed: Other studies targeting FGFR3 alterations have shown promise, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Phase 1 Part A and Part B

* Men and women 18 years of age or older.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
* Histologically confirmed advanced solid tumor who have exhausted standard therapeutic options.
* Evaluable (Part A) or measurable (Part B) disease according to RECIST v1.1.
* Histologically confirmed advanced solid tumor with an eligible FGFR3 gene mutation or fusion (Part B).

Phase 2

* Men and women 18 years of age or older.
* ECOG performance status of 0-2 or Karnofsky Performance Scale (KPS) \>70.
* At least 1 measurable lesion by RECIST v1.1.
* Histologically confirmed locally advanced/metastatic tumor in one of the following categories:

  * Urothelial carcinoma with an eligible FGFR3 gene mutation or rearrangement who have progressed on a prior FGFR inhibitor and presence of a resistance mutation or other kinase domain mutation.
  * Urothelial carcinoma with an eligible FGFR3 gene mutation or rearrangement who has not received a prior FGFR inhibitor.
  * Any solid tumor with an eligible FGFR3 gene mutation or rearrangement.

Exclusion Criteria (All Phases):

* Has a serum phosphorus level \> upper limit of normal (ULN) during screening that remains \>ULN despite medical management.
* Any ocular condition likely to increase the risk of eye toxicity.
* History of or current uncontrolled cardiovascular disease.
* Active, symptomatic, or untreated brain metastases.
* Gastrointestinal disorders that will affect oral administration or absorption of TYRA-300.
* Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.

Where this trial is running

Ocala, Florida and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Locally Advanced Urothelial CarcinomaMetastatic Urothelial CarcinomaSolid TumorUrothelial CarcinomaSolid Tumor, AdultBladder CancerNon-muscle-invasive Bladder CancerFGFR3 Gene Mutation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.