2025-523539-20-00招募中2 期
A Phase 2A/B, Multi-center, Open-Label Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Participants with Low Grade Upper Tract Urothelial Carcinoma (SURF303)
Tyra Biosciences Inc.18 个研究点 分布在 3 个国家目标入组 34 人开始时间: 2026年6月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 18
- 主要终点
- Phase 2A: 1. Complete Response rate within 6 months. 2. Determination of the recommended dose for Phase 2B based on integrated safety, PK and efficacy data
研究概览
简要总结
Phase 2A: 1. To evaluate the efficacy of dabogratinib in participants with LG UTUC with FGFR3 altered tumors. 2. To select the recommended dose for Phase 2B. Phase 2B: To evaluate the efficacy of dabogratinib in participants with LG UTUC with FGFR3 altered tumors.
研究设计
- 分配方式
- Randomized
- 主要目的
- Tyra-300
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures
- •Pathology consists of pure urothelial carcinoma
- •Adequate bone marrow, liver, and renal function.
- •Confirmed LG UTUC.
- •At least 5mm of marker lesion left behind
- •Participants must have previous genomic report or archival/fresh tissue in addition to urine sample for retrospective genomic testing
- •Identification of marker lesion(s) within 8 weeks prior to randomization
- •If synchronous NMIBC, NMIBC must be fully resected and low-grade Ta or T
- •No prior BCG administration within 1 year of date of consent
- •No intravesical chemotherapy within 8 weeks prior to C1D1 (including UGN-101).
- •No systemic chemotherapy within 3 months prior to C1D1
排除标准
- •Evidence or any features of high grade (HG) UTUC
- •Systemic immunotherapy within 6 months prior to randomization
- •Treatment with an investigational agent within 30 days or 5 half-lives from randomization, whichever is shorter; compounds with an unknown half-life will be default to 30 days.
- •Prior treatment with an intravesical or intracavitary agent within 8 weeks of C1D1
- •Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination
- •Requiring use of medications that are potential inhibitors or inducers of CYP3A (prohibited list of medications)
- •History of carcinoma in situ (CIS)
- •History of prostatic urethral involvement
- •Current or previous history of muscle invasive bladder cancer
- •Current or previous history of lymph node positive and/or metastatic bladder cancer
- •Evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma or small cell of the bladder
- •Currently receiving systemic cancer therapy (cytotoxic or immunotherapy)
- •Current or prior history of pelvic external beam radiotherapy for bladder cancer
- •Current or history of receiving a prior FGFR inhibitor
研究组 & 干预措施
null, null
Test
干预措施: null, null (Drug)
结局指标
主要结局
Phase 2A: 1. Complete Response rate within 6 months. 2. Determination of the recommended dose for Phase 2B based on integrated safety, PK and efficacy data
Phase 2A: 1. Complete Response rate within 6 months. 2. Determination of the recommended dose for Phase 2B based on integrated safety, PK and efficacy data
Phase 2B: Complete Response rate within 6 months.
Phase 2B: Complete Response rate within 6 months.
次要结局
- 1. Complete Response rate within 6 months.
- 2. Duration of Response in participants with LG UTUC with FGFR3 altered tumours; Complete Response rate in 12months and 24 months. Response rate within 6 months.
- 3. Incidence and severity of Adverse Events
- 4. PK parameters may include Cmax, Tmax, AUC0-last, AUCTau, AUC0-infinity, Vd/F, CL/F, and t1/2.
- 5. Proportion of participants who did not undergo nephrectomy or nephroureterectomy
- 6. Proportion of participants with unresectable disease at baseline who convert to resectable disease or CR on dabogratinib, as assessed by the Investigator
研究者
Doug Warner
Scientific
Tyra Biosciences Inc.
研究点 (18)
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