Phase I/II Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of SPGL008 as Monotherapy or in Combination With BCG in Patients With Non-Muscle-Invasive Bladder Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
The goal of clinical trial is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With on-Muscle-Invasive Bladder Cancer.
The main questions it aims to answer are:
- Determine the recommend Phase II dose of SPGL008 Alone or in Combination With BCG.To
- Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent in writing;
- •Age ≥ 18 years old, gender is not limited;
- •Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
- •Expected survival time ≥ 2 years;
- •High-risk NMIBC diagnosed by previous pathological biopsy
- •ineligible or unwilling to undergo radical cystectomy;
- •The level of organ function is good.
排除标准
- •Currently receiving study treatment in other clinical trials or less than 4 weeks from last participation to the first administration of this study;
- •Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration;
- •Previous medical history or examination suggests active tuberculosis within 1 year prior to the first dose;
- •Serious infection within 4 weeks before the first administration, or undefined fever>38.5 ℃ during screening/before the first administration;
- •Obvious urinary tract infections and gross hematuria, indicating safety issues assessed by the investigators;
- •Patients who discontinued treatment due to adverse reactions such as toxemia, systemic infection or urinary incontinence during previous BCG treatment
研究组 & 干预措施
SPGL008
Phase I：Phase Ia and Ib： Phase Ia include SPGL008 dose escalation and expansion; Phase Ib ： SPGL008 in combination with BCG dose escalation and expansion Phase II：SPGL008 in combination with BCG dose expansion in NMIBC
干预措施: SPGL008 (Biological)
结局指标
主要结局
Maximum tolerated dose
时间窗: Approximately 2years
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Dose-limiting toxicity
时间窗: 7 days
DLT will be defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug that occurred within the 7 days of first treatment.
Recommended Phase 2 dose (RP2D)
时间窗: Approximately 2 years.
CR Rate (cohort A)
时间窗: Approximately 4 years.
12-month DFS Rate (cohort B/C)
时间窗: Approximately 12 months
次要结局
- DFS(Approximately 4 years.)
- Time to cystectomy(Approximately 4 years.)
- Radical cystectomy rate(Approximately 4 years.)
- Treatment-Related Adverse Events as assessed by CTCAE v5.0(Approximately 4 years.)
- Duration of CR (DoR)(Approximately 4 years.)