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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
  • NTC ID: NCT05544552
  • Sponsor: Tyra Biosciences, Inc

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 2022
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Phase 1 Part A: To determine the maximum tolerated doses (MTD).

Primary Outcome 1 - Timeframe: Initiation of study treatment through 28 days.

Primary Outcome 2 - Measure: Phase 1 Part B: To determine the recommended Phase 2 dose (R2PD).

Primary Outcome 2 - Timeframe: Initiation of study treatment through 28 days (up to approximately 18 months).

Primary Outcome 3 - Measure: Phase 2: Overall Response Rate (ORR), defined by RECIST v1.1.

Primary Outcome 3 - Timeframe: Initiation of study treatment until disease progression, death, unacceptable toxicity, or withdrawal (up to 2 years).

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 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.

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

Phone: (619)728-4805

Email: TyraClinicalTrials@tyra.bio

LOCATION

Facility Status Contact
Facility: Florida Cancer Affiliates - Ocala - Main (Ocala Oncology - Ocala)
Ocala, Florida 34474
United States
Status: Recruiting Contact: Contact

352-732-4032
Facility: Prisma Health Cancer Institute - Faris
Greenville, South Carolina 29605
United States
Status: Recruiting Contact: Contact

864-679-3900
Facility: Macquarie University
Macquarie Park, New South Wales 2109
Australia
Status: Recruiting Contact: Contact

61-2-9812-3000
Facility: Tasman Oncology
Southport, Queensland 4215
Australia
Status: Recruiting Contact: Contact

61-7-5613-2480
Facility: Linear Clinical Research Limited
Nedlands, Western Australia 6009
Australia
Status: Recruiting Contact: Contact

61-1300-546-327