Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations (SURF301)
Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Solid Tumor
About this trial
This is an interventional treatment trial for Locally Advanced Urothelial Carcinoma focused on measuring 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
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.
Sites / Locations
- Florida Cancer Affiliates - Ocala - Main (Ocala Oncology - Ocala)Recruiting
- Dana Farber Cancer InstituteRecruiting
- Memorial Sloan Kettering Cancer Center (MSKCC)Recruiting
- Duke Cancer Institute (DCI) - Duke Cancer CenterRecruiting
- Prisma Health Cancer Institute - FarisRecruiting
- Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - NashvilleRecruiting
- Seattle Cancer Care Alliance (SCCA) - South Lake UnionRecruiting
- Macquarie UniversityRecruiting
- Tasman OncologyRecruiting
- Princess Alexandra HospitalRecruiting
- Austin HealthRecruiting
- Peter MacCallum Cancer Research UnitRecruiting
- Linear Clinical Research LimitedRecruiting
- Institut de Cancerologie de L'Ouest (ICO)Recruiting
- Institut Claudius Regaud, IUCT-Oncopole
- Gustave Roussy (Institut de Cancerologie Gustave-Roussy)Recruiting
- NEXT Barcelona - Hospital Quironsalud BarcelonaRecruiting
- Vall d'Hebron Institut d'Oncologia (VHIO)Recruiting
- NEXT Madrid - Hospital Universitario Quironsalud MadridRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Phase 1 Part A - dose escalation
Phase 1 Part B - dose expansion
Phase 2
TYRA-300 taken once daily by mouth in 28-day cycles starting at 10 mg daily.
TYRA-300 taken once daily by mouth in 28-day cycles.
TYRA-300 taken once daily by mouth in 28-day cycles at doses determined during Phase 1.