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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Solid Tumor, Urothelial Carcinoma, Solid Tumor, Adult, Bladder Cancer, Non-muscle-invasive Bladder Cancer, FGFR3 Gene Mutation, FGFR3 Gene Alteration, Advanced Solid Tumor, Advanced Urothelial Carcinoma, Urinary Tract Cancer, Urinary Tract Tumor, Urinary Tract Carcinoma

In brief

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations, including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract and other advanced solid tumors.

Key facts

Study ID

NCT05544552

Run by

Tyra Biosciences, Inc

People needed

310

Starts

2022-11-22

Expected to finish

2027-06-01

Last updated by the study team

2026-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• UMass Memorial Medical Center — Worchester, Massachusetts, United States
• Memorial Sloan Kettering Cancer Center (MSKCC) — New York, New York, United States
• Duke Cancer Institute (DCI) - Duke Cancer Center — Durham, North Carolina, United States
• Cleveland Clinic - Main Campus — Cleveland, Ohio, United States
• Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville — Nashville, Tennessee, United States
• Seattle Cancer Care Alliance (SCCA) - South Lake Union — Seattle, Washington, United States
• Macquarie University — Macquarie Park, New South Wales, Australia
• Tasman Oncology — Southport, Queensland, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Austin Health — Heidelberg, Victoria, Australia
• Peter MacCallum Cancer Research Unit — Melbourne, Victoria, Australia
• Linear Clinical Research Limited — Nedlands, Washington, Australia
• Institut de Cancerologie de L'Ouest (ICO) — Saint-Herblain, France
• Institut Claudius Regaud, IUCT-Oncopole — Toulouse, France
• Gustave Roussy (Institut de Cancerologie Gustave-Roussy) — Villejuif, France
• NEXT Barcelona - Hospital Quironsalud Barcelona — Barcelona, Spain
• Vall d'Hebron Institut d'Oncologia (VHIO) — Barcelona, Spain
• NEXT Madrid - Hospital Universitario Quironsalud Madrid — Madrid, Spain

Full record on ClinicalTrials.gov

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