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Brief Title: Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors

A Multicenter, Open-label Phase 1/2 Study of TYRA300 in Advanced Urothelial Carcinoma and Other Solid Tumors With Activating FGFR3 Gene Alterations (SURF301)

INTRODUCTION

  • Org Study ID: TYR300-101
  • Secondary ID: N/A
  • NCT ID: NCT05544552
  • Sponsor: Tyra Biosciences, Inc

DESCRIPTION

The SURF301 study is evaluating TYRA-300 for the first time in patients with metastatic
urothelial cancer (bladder cancer) and other types of metastatic cancers with FGFR3 gene
alterations.

TYRA-300 is being developed as a personalized oral therapy that targets specific alterations (or
abnormalities) in the FGFR3 gene. The FGFR3 gene is altered in 15-20% of metastatic urothelial
cancers. Tumors with these alterations can respond to drugs that target FGFR3. Most approved
and experimental drugs target FGFR3 but also target other FGFR family members, which may
lead to side effects that can interfere with quality of life or result in treatment discontinuation.
In addition, tumors being treated with these medicines can become resistant to these drugs by
mutating. TYRA-300 was designed to be more selective for FGFR3 and less likely fail despite the
presence of specific mutations. Moreover, by closely targeting the FGFR3 gene, it is believed
the development of certain side effects may be reduced.

BRIEF 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.

  • Overall Status
    Recruiting
  • Start Date
    November 22, 2022
  • Phase
    PHASE1, PHASE2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

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

ELIGIBILITY

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

OFFICIAL INFORMATION

Name: Hiroomi Tada, M.D., Ph.D.

Role: Study Chair

Affiliation: Tyra Biosciences, Inc

Overall Contact

Name: Jennifer M Davis

Phone: (619)728-4805

Email: TyraClinicalTrials@tyra.bio

LOCATION

Facility Status Contact
Facility: Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States 		Status: Recruiting Contact: Contact

617-632-3000
Facility: UMass Memorial Medical Center
Worcester, Massachusetts 01655
United States 		Status: Recruiting Contact: Contact

508-334-1000
Facility: Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York 10021
United States 		Status: Recruiting Contact: Contact

212-639-2000
Facility: Duke Cancer Institute (DCI) - Duke Cancer Center
Durham, North Carolina 27710
United States 		Status: Recruiting Contact: Contact

919-668-4615
Facility: Cleveland Clinic - Main Campus
Cleveland, Ohio 44195
United States 		Status: Recruiting Contact: Contact

216-444-2200
Facility: Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville
Nashville, Tennessee 37232
United States 		Status: Recruiting Contact: Contact

615-936-1782
Facility: Seattle Cancer Care Alliance (SCCA) - South Lake Union
Seattle, Washington 98109
United States 		Status: Recruiting Contact: Contact

855-557-0555

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