RECRUITING

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

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Conditions

Locally Advanced Urothelial CarcinomaMetastatic Urothelial CarcinomaSolid TumorUrothelial CarcinomaSolid Tumor, AdultBladder CancerNon-muscle-invasive Bladder CancerFGFR3 Gene MutationFGFR3 Gene AlterationAdvanced Solid TumorAdvanced Urothelial CarcinomaUrinary Tract CancerUrinary Tract TumorUrinary Tract CarcinomabladderFGFR3 gene activationFGFR3 gene alterationsFGFR3 gene fusion/rearrangementFGFR3 gene translocationFGFR3 positiveFibroblast growth factor receptor 3 (FGFR3)Fibroblast growth factor receptor 3 alterationslocally advanced cancermetastatic cancersolid tumorsurothelial cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-11-22
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05544552

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women 18 years of age or older.
  2. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
  3. * Histologically confirmed advanced solid tumor who have exhausted standard therapeutic options.
  4. * Evaluable (Part A) or measurable (Part B) disease according to RECIST v1.1.
  5. * Histologically confirmed advanced solid tumor with an eligible FGFR3 gene mutation or fusion (Part B).
  6. * Men and women 18 years of age or older.
  7. * ECOG performance status of 0-2 or Karnofsky Performance Scale (KPS) \>70.
  8. * At least 1 measurable lesion by RECIST v1.1.
  9. * Histologically confirmed locally advanced/metastatic tumor in one of the following categories:
  10. * 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.
  11. * Urothelial carcinoma with an eligible FGFR3 gene mutation or rearrangement who has not received a prior FGFR inhibitor.
  12. * Any solid tumor with an eligible FGFR3 gene mutation or rearrangement.
  13. * Has a serum phosphorus level \> upper limit of normal (ULN) during screening that remains \>ULN despite medical management.
  14. * Any ocular condition likely to increase the risk of eye toxicity.
  15. * History of or current uncontrolled cardiovascular disease.
  16. * Active, symptomatic, or untreated brain metastases.
  17. * Gastrointestinal disorders that will affect oral administration or absorption of TYRA-300.
  18. * Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Grace Indyk
CONTACT
(619)728-4805
TyraClinicalTrials@tyra.bio

Principal Investigator

Doug Warner
STUDY_CHAIR
Tyra Biosciences, Inc

Study Locations (Sites)

Florida Cancer Affiliates - Ocala - Main (Ocala Oncology - Ocala)
Ocala, Florida, 34474
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York, 10021
United States
Duke Cancer Institute (DCI) - Duke Cancer Center
Durham, North Carolina, 27710
United States
Cleveland Clinic - Main Campus
Cleveland, Ohio, 44195
United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
United States
Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville
Nashville, Tennessee, 37232
United States
Seattle Cancer Care Alliance (SCCA) - South Lake Union
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Tyra Biosciences, Inc

  • Doug Warner, STUDY_CHAIR, Tyra Biosciences, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-22
Study Completion Date2027-06

Study Record Updates

Study Start Date2022-11-22
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • bladder
  • FGFR3 gene activation
  • FGFR3 gene alterations
  • FGFR3 gene fusion/rearrangement
  • FGFR3 gene mutation
  • FGFR3 gene translocation
  • FGFR3 positive
  • Fibroblast growth factor receptor 3 (FGFR3)
  • Fibroblast growth factor receptor 3 alterations
  • locally advanced cancer
  • metastatic cancer
  • solid tumors
  • urothelial cancer
  • urothelial carcinoma
  • Urinary tract cancer
  • Urinary tract tumor
  • Urinary tract carcinoma

Additional Relevant MeSH Terms

  • 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