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

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.

Conditions

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Locally Advanced Urothelial Carcinoma
Intervention / Treatment

-

Contacts and Locations

Ocala

Florida Cancer Affiliates - Ocala - Main (Ocala Oncology - Ocala), Ocala, Florida, United States, 34474

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Worcester

UMass Memorial Medical Center, Worcester, Massachusetts, United States, 01655

New York

Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York, United States, 10021

Durham

Duke Cancer Institute (DCI) - Duke Cancer Center, Durham, North Carolina, United States, 27710

Cleveland

Cleveland Clinic - Main Campus, Cleveland, Ohio, United States, 44195

Greenville

Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States, 29605

Nashville

Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville, Nashville, Tennessee, United States, 37232

Seattle

Seattle Cancer Care Alliance (SCCA) - South Lake Union, Seattle, Washington, United States, 98109

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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).
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Tyra Biosciences, Inc,

Doug Warner, STUDY_CHAIR, Tyra Biosciences, Inc

Study Record Dates

2027-06