Trial Title:
Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations
NCT ID:
NCT05544552
Condition:
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
Conditions: Official terms:
Carcinoma
Neoplasms
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Non-Muscle Invasive Bladder Neoplasms
Urologic Neoplasms
Conditions: Keywords:
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
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TYRA-300
Description:
TYRA-300 is an oral, novel potent FGFR 3-selective tyrosine kinase inhibitor that targets
tumors that contain activating gene alterations of FGFR3.
Arm group label:
Phase 1 Part A - dose escalation
Arm group label:
Phase 1 Part B - dose expansion
Arm group label:
Phase 2
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.
Detailed 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.
Criteria for 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 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Florida Cancer Affiliates - Ocala - Main (Ocala Oncology - Ocala)
Address:
City:
Ocala
Zip:
34474
Country:
United States
Status:
Withdrawn
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Phone:
617-632-3000
Facility:
Name:
UMass Memorial Medical Center
Address:
City:
Worcester
Zip:
01655
Country:
United States
Status:
Recruiting
Contact:
Phone:
508-334-1000
Facility:
Name:
Memorial Sloan Kettering Cancer Center (MSKCC)
Address:
City:
New York
Zip:
10021
Country:
United States
Status:
Recruiting
Contact:
Phone:
212-639-2000
Facility:
Name:
Duke Cancer Institute (DCI) - Duke Cancer Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Phone:
919-668-4615
Facility:
Name:
Cleveland Clinic - Main Campus
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Phone:
216-444-2200
Facility:
Name:
Prisma Health Cancer Institute - Faris
Address:
City:
Greenville
Zip:
29605
Country:
United States
Status:
Withdrawn
Facility:
Name:
Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Contact:
Phone:
615-936-1782
Facility:
Name:
Seattle Cancer Care Alliance (SCCA) - South Lake Union
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Phone:
855-557-0555
Facility:
Name:
Macquarie University
Address:
City:
Macquarie Park
Zip:
2109
Country:
Australia
Status:
Recruiting
Contact:
Phone:
61-2-9812-3000
Facility:
Name:
Tasman Oncology
Address:
City:
Southport
Zip:
4215
Country:
Australia
Status:
Recruiting
Contact:
Phone:
61-7-5613-2480
Facility:
Name:
Princess Alexandra Hospital
Address:
City:
Woolloongabba
Zip:
4102
Country:
Australia
Status:
Recruiting
Contact:
Phone:
61-7-3176-2111
Facility:
Name:
Austin Health
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Status:
Recruiting
Contact:
Phone:
61-3-9496-5000
Facility:
Name:
Peter MacCallum Cancer Research Unit
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Contact:
Phone:
61-1800-111-440
Facility:
Name:
Linear Clinical Research Limited
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Contact:
Phone:
61-1300-546-327
Facility:
Name:
Institut de Cancerologie de L'Ouest (ICO)
Address:
City:
Saint Herblain
Zip:
44805
Country:
France
Status:
Recruiting
Contact:
Phone:
33-(0)-2-40-67-99-77
Facility:
Name:
Institut Claudius Regaud, IUCT-Oncopole
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Contact:
Phone:
33-(0)-5-31-15-58-10
Facility:
Name:
Gustave Roussy (Institut de Cancerologie Gustave-Roussy)
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Contact:
Phone:
33-(0)-1-42-11-42-11
Facility:
Name:
NEXT Barcelona - Hospital Quironsalud Barcelona
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Status:
Recruiting
Contact:
Phone:
34-93-238-16-61
Facility:
Name:
Vall d'Hebron Institut d'Oncologia (VHIO)
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Phone:
34-93-254-34-50
Facility:
Name:
NEXT Madrid - Hospital Universitario Quironsalud Madrid
Address:
City:
Madrid
Zip:
28223
Country:
Spain
Status:
Recruiting
Contact:
Phone:
34-902-08-98-00
Start date:
November 22, 2022
Completion date:
June 2027
Lead sponsor:
Agency:
Tyra Biosciences, Inc
Agency class:
Industry
Source:
Tyra Biosciences, Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05544552
