Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This trial is investigating TYRA-300, a new FGFR3-selective tyrosine kinase inhibitor, in cancers with FGFR3 activating gene alterations including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract and other advanced solid cancers.
Phase 1 is a dose-escalation study, with two parts. In Part A (dose-escalation), participants will receive TYRA-300 (taken once daily by mouth in 28-day cycles) in increasing doses, starting at 10mg daily. In Part B (dose-expansion), participants will receive TYRA-300 (orally, once daily in 28-day cycles) to continue to study the safety and effect at certain doses.
In Phase 2, participants will receive TYRA-3000 (orally, once daily in 28-day cycles) at the recommended doses determined during Phase 1.
Conditions
This trial is treating people with cancers with FGFR3 activating gene alterations, including locally advanced or metastatic urothelial carcinoma of the bladder and urinary tract and other advanced solid cancers
Eligibility
Inclusion
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
Exclusion
- 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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Tyra Biosciences, Inc
Scientific 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)
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