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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tyra Biosciences, Inc
Study ID
NCT05544552
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TYRA-300 — DRUG
    TYRA-300 is an oral, novel potent FGFR 3-selective tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR3.

Study Details

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 Dates

Start date
Nov 22, 2022
Status verified
Jan 2026
Primary completion
Nov 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
310 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Part A - dose escalation
    TYRA-300 taken once daily by mouth in 28-day cycles starting at 10 mg daily.
  • Experimental: Phase 1 Part B - dose expansion
    TYRA-300 taken once or twice daily by mouth in 28-day cycles.
  • Experimental: Phase 2
    TYRA-300 taken once or twice daily by mouth in 28-day cycles at doses determined during Phase 1.

Primary Outcome Measure

Phase 1 Part A: To determine the maximum tolerated doses (MTD). [ Time Frame: Initiation of study treatment through 28 days. ]

Locations (7)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-
UMass Memorial Medical CenterWorchesterMassachusetts01655-
Memorial Sloan Kettering Cancer Center (MSKCC)New YorkNew York10021-
Duke Cancer Institute (DCI) - Duke Cancer CenterDurhamNorth Carolina27710-
Cleveland Clinic - Main CampusClevelandOhio44195-
Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - NashvilleNashvilleTennessee37232-
Seattle Cancer Care Alliance (SCCA) - South Lake UnionSeattleWashington98109-

Find similar trials in Boston, MA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Dana Farber Cancer Institute· Boston, MAUMass Memorial Medical Center· Worchester, MAMemorial Sloan Kettering Cancer Center (MSKCC)· New York, NYDuke Cancer Institute (DCI) - Duke Cancer Center· Durham, NCCleveland Clinic - Main Campus· Cleveland, OHVanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville· Nashville, TN

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