NCT07265947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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 26
- 主要终点
- To assess the efficacy of Dabogratinib in LG UTUC FGFR3+ participants (proportion of participants with a CR within 6 months out of all LG UTUC FGFR3+ participants)
研究概览
简要总结
A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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
- •Confirmed LOW RISK LG UTUC (both favorable and unfavorable) per AUA
- •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 (refer to Inclusion Criterion #2)
- •If synchronous NMIBC, NMIBC must be fully resected and low-grade Ta or T1
- •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
- •Pathology consists of pure urothelial carcinoma
- •Adequate bone marrow, liver, and renal function:
- •i. Absolute neutrophil count (ANC) ≥1,500/mm3 ii. Platelet count ≥75,000/mm3 iii. Hemoglobin ≥10.0 g/dL
- •i. Total bilirubin ≤ ULN ii. Alanine aminotransferase (ALT) ≤ ULN iii. Aspartate aminotransferase (AST) ≤ ULN
- •Estimated glomerular filtration rate >60 mL/min
- •Serum Phosphate level ≤ ULN prior to starting treatment
- •International normalized ratio (INR) ≤1.5 × ULN
排除标准
- •Evidence or any features of high grade (HG) UTUC
- •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
- •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 C1D
- •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)
研究组 & 干预措施
Study Drug Dose Cohort A (DCA) 60mg
Experimental
Dabogratinib (TYRA-300) monotherapy in Participants
干预措施: Dabogratinib (TYRA-300) 60mg (Drug)
Possible Study Drug Dose Cohort C (DCC) TBD mg
Experimental
Dabogratinib (TYRA-300) monotherapy in Participants
干预措施: Dabogratinib (TYRA-300) TBD (Drug)
Study Drug Dose Cohort B (DCB) 80mg
Experimental
Dabogratinib (TYRA-300) monotherapy in Participants
干预措施: Dabogratinib (TYRA-300) 80mg (Drug)
结局指标
主要结局
To assess the efficacy of Dabogratinib in LG UTUC FGFR3+ participants (proportion of participants with a CR within 6 months out of all LG UTUC FGFR3+ participants)
时间窗: within 6 months
Complete response (CR) rate
次要结局
- Duration of Response (DOR)(median time for CR duration in those participants who achieve a CR)(up to 36 months)
- Complete Response (proportion of participants who continue to have a CR at 12 and 24 months)(at 12 and 24 months)
- Rate of renal preservation after treatment with dabogratinib(Up to 2 years)
- Change from unresectable UTUC to resectable UTUC(Up to 2 years)
- To assess the efficacy of Dabogratinib in LG UTUC in all participants (proportion of participants with a CR within 6 months out of all LG UTUC participants)(at 6 months)
- Duration of Response (DOR)(median time for CR duration in those participants who achieve a CR)(up to 36 months)
- Complete Response (proportion of participants who continue to have a CR at 12 and 24 months)(at 12 and 24 months)
- Safety and tolerability of dabogratinib(Up to 2 years)
- Rate of renal preservation after treatment with dabogratinib(Up to 2 years)
- Change from unresectable UTUC to resectable UTUC(Up to 2 years)
研究者
研究点 (26)
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