A Multicenter Phase II Study of RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive High-risk Non-muscle-invasive Bladder Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- 12-month recurence-free survival rate
研究概览
简要总结
This study will evaluate the efficacy and safety of intravenous RC48-ADC in adjuvant/salvage treatment of HER2 positive high-risk non-muscle-invasive bladder cancer.
详细描述
This study is a multicenter phase II study, which aims to evaluate the efficacy and safety of intravenous RC48-ADC in adjuvant/salvage treatment of HER2 positive high-risk non-muscle-invasive bladder cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be willing and able to provide written informed consent/assent for the trial.
- •Life expectancy ≥12 weeks.
- •Have a histologically-confirmed diagnosis of high-risk non-muscle-invasive (according to 2023 NCCN guidelines for bladder cancer) transitional cell carcinoma of the bladder. Subjects with tumors of mixed transitional/non-transitional cell histology are allowed, but transitional cell carcinoma must be the predominant histology.
- •Have been treated with adequate BCG therapy and failed (according to 2023 EAU guidelines for NMIBC, for salvage treatment arm).
- •Have elected not to undergo, or are considered ineligible for radical cystectomy, as determined by the treating surgeon.
- •Have tumor tissues for HER2 IHC evaluation and have a HER2 expression score of HER2 2+ or HER2 3+ reviewed by an independent pathologist at the central laboratory.
- •Have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- •Demonstrate adequate organ function.
- •Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication.
- •Male subjects of childbearing potential (Section 5.7.2) must agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy.
排除标准
- •Has muscle-invasive (i.e. T2, T3, T4) locally advanced non-resectable or metastatic urothelial carcinoma.
- •Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium.
- •Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- •Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy/TURBT to starting trial treatment. (Note: A single dose of intravesical treatment given as part of the most recent cystoscopy/TURBT, during the screening period, such as with chemotherapy as per local / regional practices, is acceptable.).
- •Allergic to study therapy.
- •Has a known additional malignancy that has had progression or has required active treatment in the last five years.
- •Has an active autoimmune disease that has required systemic treatment in past 2 years.
- •Have diseases that may interfere with the study treatment or severe and uncontrolled concomitant diseases.
- •Has had an allogeneic tissue/solid organ transplant.
研究组 & 干预措施
Adjuvant RC48-ADC
In this arm, RC48-ADC is evaluated in patients with HER2-positive high-risk non-muscle-invasive bladder cancer as an adjuvant treatment.
干预措施: RC48-ADC (Drug)
Salvage RC48-ADC
In this arm, RC48-ADC is evaluated in patients with HER2-positive non-muscle-invasive bladder cancer who failed BCG treatment as an adjuvant treatment.
干预措施: RC48-ADC (Drug)
结局指标
主要结局
12-month recurence-free survival rate
时间窗: From treatment initiation to 12 month
The probability of patients remaining free of high-risk NMIBC or worse for at least 12 months after first dose of RC48-ADC adjuvant treatment
3-month pathological complete response rate
时间窗: From treatment initiation to 3 month
The proportion of patients are negative for urine cytology and cystoscopy at 3 month after first dose of RC48-ADC salvage treatment
Adverse events
时间窗: From patient screening to 30 days after end of cycle 6
The type, incidence, relatedness, and severity of adverse events
次要结局
- 6-month recurence-free survival rate(From treatment initiation to 6 month)
- Overall survival(From time of first dose of RC48-ADC treatment to up to 60 months)
- Quality of life assessed by EQ-5D scale(After every cycle of treatment and 30 days after end of cycle 6)
- Recurrence-free survival(From time of first dose of RC48-ADC adjuvant treatment to up to 60 months)
- Duration of response(From time of complete response to up to 60 months)
- Progression-free survival(From time of first dose of RC48-ADC treatment to up to 60 months)