NCT06995677招募中2 期
A Phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302)
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
- 90
- 试验地点
- 57
- 主要终点
- To assess the efficacy of TYRA-300 in LG IR-NMIBC participants
研究概览
简要总结
Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
详细描述
A Phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of TYRA-300 in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
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 age 18 and over of informed consent and willing and able to comply with all requires study procedures
- •Able to understand and given written informed consent
- •Participants with histologically confirmed low-grade NMIBC within 6 weeks prior to randomization with prior diagnostic biopsy/TURBT to confirm stage and grade and with at least 3 mm and no more than 12 mm total (1/2 a resectoscope loop to 2 loops, refer to Section 8.1.5) residual visible tumor as a marker lesion(s) left behind:
- •Ta low grade
- •T1 low grade
- •Participants must have intermediate risk NMIBC, defined as having any of the following characteristics (AUA Guidelines, 2024)
- •Recurrence within 1 year, LG Ta
- •Solitary LG Ta >3cm
- •LG Ta, multifocal
- •Documented activating FGFR3 mutation or fusion (Appendix 4)
- •Have undergone bladder mapping and identification of visible marker lesion(s) within 6 weeks prior to randomization (refer to Inclusion Criterion #3)
- •No evidence of urothelial carcinoma of the upper urinary tract (confirmed by imaging) or prostatic urethra within 6 months of randomization
- •No prior BCG administration within 1 year of date of consent.
- •No intravesical chemotherapy within 8 weeks prior to C1D
- •Pathology consistent with pure urothelial carcinoma; if mixed histology, ensure that at least 80% of the sample is urothelial
- •Adequate bone marrow, liver, and renal function:
- •b. Bone marrow function: i. Absolute neutrophil count (ANC) > or = 1,500/mm3 ii. Platelet count > or = 75,000/mm3 iii. /hemoglobin > or = 10.0 g/dL e. Liver function: i.Total bilirubin < or = ULN ii. Alanine aminotransferase (ALT) < or = ULN iii. Aspartate aminotransferase (AST) < or = ULN f. Renal function: i. estimated glomerular filtration rate >60 mL/min calculated using the modification of diet in renal disease equation or CKD-EPI formula ii. Serum Phosphate level < or = ULN prior to starting treatment g. Coagulation i. International normalized ratio (INR) < or = 1.5 x ULN
- •Ability to swallow tablets
- •Participants (male and female) of child-bearing potential (including females who are post-menopausal for less than 1 year) must be willing to practice effective contraception while on treatment and be willing and able to continue contraception for 3 months (males) and 6 months (females) after the last dose of study treatment. Potential male participants should consider the potential impact of TYRA-300 on their ability to father a child and discuss options with the site study staff.
- •Potential participants who are positive for human immunodeficiency virus (HIV) must have a viral load below the limits of detection and on stable antiretroviral therapy for at least 3 months prior to C1D
- •NOTE: some of the compounds in antiretroviral therapy may be on the prohibited medications list. Allowances will be made to ensure the participant's HIV treatment continues uninterrupted following a discussion with the Sponsor's medical monitor. A discussion of the impact of the antiretroviral therapy on TYRA- 300 needs to be discussed with the potential participant prior to C1D
- •Potential participants with chronic hepatitis B virus (HBV) infection with active disease should be on a suppressive antiviral therapy prior to C1D
- •Potential participants patients with a history of hepatitis C virus (HCV) infection should have completed curative antiviral treatment and must have a HCV viral load below the limit of quantification.
- •Potential participants with a history of HCV infection and on current treatment must have a HCV viral load below the limit of quantification
排除标准
- •Presence of tumor in ureter or prostatic urethra:
- •Current or previous history of muscle invasive bladder cancer
- •Current or previous history of lymph node positive and/or metastatic bladder cancer
- •Evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure undifferentiated carcinoma of the bladder
- •Currently receiving systemic cancer therapy (cytotoxic, immunotherapy, targeted)
- •Currently receiving treatment with a prohibited therapy (refer to Section 6.7.1)
- •Current or prior history of pelvic external beam radiotherapy
- •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 default to the 30 days.
- •Prior treatment with an intravesical agent within 8 weeks prior to C1D1
- •Current ongoing toxicity from previous therapy
- •Had major surgery within 4 weeks prior to C1D1
- •Any reason that in the view of the investigator, would substantially impair the ability of the participant to comply with study procedures and/or risk to the participant (i.e., uncontrolled diabetes)
- •Females who are pregnant, breastfeeding or planning to become pregnant within 6 months after the last dose of TYRA-300 and males who plan to father a child while enrolled in this study or within 3 months after the last dose of TYRA-300
- •Has impaired wound healing capacity
- •Serum phosphate levels above the upper limit of normal during screening
- •Any ocular condition likely to increase the risk of eye toxicity
- •Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination.
- •History of or current uncontrolled cardiovascular disease
- •Gastrointestinal disorders that will affect oral administration or absorption of TYRA-300
- •Known history of HIV infection, or active hepatitis B or C
- •History of a second primary malignancy within 3 years of signing ICF, except for nonmelanoma skin cancer and cured and active surveillance malignancies (i.e., prostate, breast) .
- •Known allergy to TYRA-300 or any excipients of the formulated product
- •Participants taking strong inhibitors and/or inducers of CYP3A4 enzyme
- •History of prolonged QT syndrome or baseline heart rate-corrected QT interval using Fridericia formula (QTcF) interval >470 ms
研究组 & 干预措施
Dose Cohort B (DCB)
Experimental
TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
干预措施: TYRA-300 50mg (Drug)
Dose Cohort A (DCA)
Experimental
TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
干预措施: TYRA-300 60mg (Drug)
Possible Dose Cohort C (DCC)
Experimental
To Be Determined- TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
干预措施: TYRA-300 Dose TBD (Drug)
结局指标
主要结局
To assess the efficacy of TYRA-300 in LG IR-NMIBC participants
时间窗: at 3 months
Complete response (CR) rate
次要结局
- Duration of response (responders only)(time from initial response to confirmed recurrence of disease or death, up to 24 months)
- Time to recurrence (responders only)(time from start of response to confirmed recurrence of disease, up to 24 months)
- Recurrence-free survival rate (responders only)(at 12 months and 24 months)
- Progression-free survival (all participants)(time from randomization to the progression of disease or death from any cause, whichever occurs first, up to 24 months)
- Incidence and severity of adverse events(Up to 2 years)
- To assess the safety and tolerability of TYRA-300 in LG IR-NMIBC participants(From initiation of treatment to 2 years)
研究者
研究点 (57)
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