Bladder Cancer Clinical Trial

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

Summary

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.

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Full Description

This is a single arm, multi-part, phase 1/2 global trial studying TYRA-300, a novel, potent fibroblast growth factor receptor (FGFR) 3-selective tyrosine kinase inhibitor, in advanced/metastatic urothelial carcinoma of the bladder and urinary tract, that contain activating gene alterations of FGFR3. Phase 1 is a dose-escalation study to evaluate the safety, tolerability, and PK of TYRA-300 to determine the optimal and maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Phase 2 will evaluate the 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.

View Eligibility Criteria

Eligibility 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 12 years of age or older.
ECOG performance status of 0-2 or Karnofsky Performance Scale (KPS) >70 for participants aged 12 to 17 years.
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.

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

310

Study ID:

NCT05544552

Recruitment Status:

Recruiting

Sponsor:

Tyra Biosciences, Inc

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There are 21 Locations for this study

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Florida Cancer Affiliates - Ocala - Main (Ocala Oncology - Ocala)
Ocala Florida, 34474, United States More Info
Contact
352-732-4032
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Contact
617-632-3000
Memorial Sloan Kettering Cancer Center (MSKCC)
New York New York, 10021, United States More Info
Contact
212-639-2000
Duke Cancer Institute (DCI) - Duke Cancer Center
Durham North Carolina, 27710, United States More Info
Contact
919-668-4615
Fox Chase Cancer Center - Temple Health
Rockledge Pennsylvania, 19046, United States More Info
Contact
445-220-6579
Prisma Health Cancer Institute - Faris
Greenville South Carolina, 29605, United States More Info
Contact
864-679-3900
Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville
Nashville Tennessee, 37232, United States More Info
Contact
615-936-1782
Seattle Cancer Care Alliance (SCCA) - South Lake Union
Seattle Washington, 98109, United States More Info
Contact
855-557-0555
Macquarie University
Macquarie Park New South Wales, 2109, Australia More Info
Tasman Oncology
Southport Queensland, 4215, Australia More Info
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia More Info
Southern Oncology Research Unit Pty Ltd.
Bedford Park South Australia, 5042, Australia More Info
Austin Health
Heidelberg Victoria, 3084, Australia More Info
Peter MacCallum Cancer Research Unit
Melbourne Victoria, 3000, Australia More Info
Linear Clinical Research Limited
Nedlands Western Australia, 6009, Australia More Info
Institut de Cancerologie de L'Ouest (ICO)
Saint Herblain , 44805, France More Info
Institut Claudius Regaud, IUCT-Oncopole
Toulouse , 31059, France More Info
Gustave Roussy (Institut de Cancerologie Gustave-Roussy)
Villejuif , 94805, France More Info
NEXT Barcelona - Hospital Quironsalud Barcelona
Barcelona , 08023, Spain More Info
Vall d'Hebron Institut d'Oncologia (VHIO)
Barcelona , 08035, Spain More Info
NEXT Madrid - Hospital Universitario Quironsalud Madrid
Madrid , 28223, Spain More Info

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

310

Study ID:

NCT05544552

Recruitment Status:

Recruiting

Sponsor:


Tyra Biosciences, Inc

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