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

Launched by TYRA BIOSCIENCES, INC · Sep 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called TYRA-300 for patients with certain types of advanced cancers, particularly urothelial carcinoma, which affects the bladder and urinary tract. The goal is to find out how safe this treatment is and whether it can help reduce tumors in patients who have specific changes in a gene called FGFR3. This trial is open to adults aged 18 and older who have advanced solid tumors and have already tried other standard treatments without success.

To be eligible for the trial, participants should have a good level of health and be able to perform daily activities. They must have a confirmed diagnosis of advanced cancer with certain gene changes, and their disease must be measurable. During the trial, participants will receive the study drug and will be monitored closely for any side effects or improvements in their condition. It’s important to know that individuals with specific health issues, like uncontrolled heart problems or certain eye conditions, may not be able to participate. This trial is still recruiting participants, so there’s an opportunity for those who qualify to be part of this important research.

Gender

ALL

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.