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RecruitingLast updated: 2 February 2024

SURF301: This phase I/II study is evaluating how safe, tolerable and effective a new drug (TYRA-300) is in people certain cancers with FGFR3 activating gene alterationsA Multicenter, Open-label Phase 1/2 Study of TYRA300 in Advanced Urothelial Carcinoma and Other Solid Tumors With Activating FGFR3 Gene Alterations (SURF301)

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 patients 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

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

Trial Acronym

SURF301

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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)

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

  • 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

  • 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

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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