NCT06588179尚未招募1 期
Phase Ib/II Clinical Study of SHR-1501 Combined With SHR-2005 in the Treatment of Patients With High-Risk Non-Muscle Invasive Bladder Cancer Which is Not Completely Resectable by TURBt
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Phase I : Incidence of dose limiting toxicities (DLTs)
研究概览
简要总结
This is a single-center, single-arm, phase Ib/II study, aimed at assessing the safety and efficacy of SHR-1501 in combination with SHR-2005 as treatment for patients with high-risk non-muscle invasive bladder cancer (HR NMIBC) which is not completely resectable by transurethral resection of bladder tumor (TURBt).
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
- •Age ≥18 years old, both genders
- •Previous pathological biopsy was diagnosed as high-risk NMIBC
- •Tumors cannot be completely resected by TURBT（at least 2 senior urologists assessed that the lesion area is too extensive to be completely resected）
- •Ineligible or unwilling to undergo radical cystectomy
- •TURBT was performed within 6 weeks
- •Agreed to provide cystoscopic biopsy specimens for review
- •ECOG performance status of 0-2
- •Life expectancy ≥ 2 years
- •Adequate organ function：
- •Hematological indexes: ANC ≥1.5x10^9/L, PLT ≥100x10^9/L, Hb ≥ 90 g/L;
- •Liver function: TBIL ≤1.5 ULN; ALT and AST≤2.5 ULN; Albumin > 3g/dL
- •Renal function: Cr≤1.5 ULN or creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula); if proteinuria ≥++, requiring 24-hour urine protein level ≤1.0g;
- •ECG: females QTcF ≤470ms and males ≤450ms
- •Cardiac ultrasound: LVEF≥50%
- •Coagulation: INR or PT ≤1.5 ULN，APTT≤1.5 ULN
- •Female or male subjects of childbearing age who have not undergo surgical sterilization shall agree to use contraceptive measures (such as intrauterine device and contraceptive pill) during the study treatment period and within 3 months after the end of the study treatment period, and both female subjects and female partners of male subjects should use highly effective contraceptive methods; the Female subjects of childbearing age who have not undergone surgical sterilization must have a negative serum HCG test result within 7 days prior to the first administration and must be non-lactating.
- •Volunteered to join the study, signed the informed consent, and had good compliance with follow-up
排除标准
- •Previous pathological biopsy was diagnosed with muscle-invasive bladder cancer at T2 or higher stages
- •Received any other intravesical chemotherapy treatment within 2 weeks or received any other clinical drugs within 4 weeks
- •History of allergy to any of the study drugs or study drug components
- •Upper urinary tract tumor detected by CTU or MRU during screening period or other concomitant malignant tumors within 5 years before the first administration
- •Previously received any TNFR agonist antibody therapy(such as OX40, CD27, CD357 antibodies), IL-15 agonist antibody therapy, or IL-2 agonist antibody therapy
- •Oversize surgery or severe trauma within 4 weeks before the first use of research drugs
- •Previously discontinued bladder instillation therapy due to adverse reactions such as sepsis, systemic infection, or urinary incontinence
- •Active/uncontrolled impairment of the urogenital system, kidneys, liver, gallbladder, cardiovascular system, gastrointestinal tract, nervous system, or hematopoietic system, which may lead to complications for the subject when receiving intravesical therapy and/or general anesthesia
- •A history of interstitial lung disease or non-infectious pneumonitis requiring treatment with glucocorticoids, or current presence of interstitial pneumonitis or non-infectious pneumonitis, or a history of other severe pulmonary diseases
- •A history of immunodeficiency, including HIV seropositivity, other acquired or congenital immunodeficiency diseases, a history of organ transplantation, or current use of immunosuppressants
- •History of clinically significant cardiovascular disease within 6 months before the first administration
- •Investigator-assessed concern for medication safety; severe infections requiring antibiotic, antiviral or antifungal drug control; and unexplained fever > 38.5°C within 2 weeks
- •Patient with active hepatitis B (HBeAg positive and HBV DNA≥500 IU/mL), hepatitis C (HCV antibody positive and HCV RNA higher than the detection limit of the analytical method)
- •Adverse reactions of previous anti-tumor treatment have not recovered to Grade≤1 per NCI-CTCAE v5.0
- •The presence of any other conditions that the investigator deems inappropriate to participate in this study, including serious physical or mental illness, abnormal laboratory tests, and other factors that may increase the risk of participating in the study, or interfere with the results of the study
研究组 & 干预措施
Arm：SHR-1501+SHR-2005
Experimental
干预措施: SHR-1501+SHR-2005 (Drug)
结局指标
主要结局
Phase I : Incidence of dose limiting toxicities (DLTs)
时间窗: From Day 1 to Day 21
Phase I : RP2D（Recommended Phase 2 dose）
时间窗: From Day 1 to 90 days after last dose
Phase I : Incidence and severity of adverse events (AEs)
时间窗: From Day 1 to 90 days after last dose
Phase II : CR rate at 3 months
时间窗: Approximately 2 years
次要结局
- Phase I : CR rate at 3 months(From Day 1 to 90 days after last dose)
- Phase II : Incidence and severity of adverse events (AEs)(Approximately 2 years)
- Phase Ib/II: PR rate at 3 months(Approximately 2 years)
- Phase Ib/II: CR rate at 6 months and 12months(Approximately 2 years)
- Phase Ib/II: Duration of CR (DoR)(Approximately 2 years)
- Phase Ib/II: Cystectomy-Free Survival (CFS)(Approximately 2 years)
研究者
Ding-Wei Ye
Chief Physician
Fudan University
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib in Patients With Advanced HCC(RESCUE)Hepatocellular CarcinomaNCT03463876Jiangsu HengRui Medicine Co., Ltd.190
尚未招募
2 期
SHR-1701 for Consolidation Therapy After Concurrent Chemoradiotherapy in Inoperable Stage III NSCLCNSCLC, Stage IIINCT05177497Shanghai Chest Hospital19
Unknown
1 期
Study of SHR2150 (TLR7 Agonist) in Combination With Chemotherapy Plus PD-1 or CD47 Antibody in Subjects With Unresectable/ Metastatic Solid TumorsSolid TumorNCT04588324Chinese PLA General Hospital50
Unknown
2 期
A Trial of SHR-1701 in Combination With and Without Famitinib Malate in Patients With Extensive Stage Small Cell Lung CancerLung CancerNCT04884009Jiangsu HengRui Medicine Co., Ltd.106
已完成
1 期
A Study of SHR-1501 Combined With SHR-1316 in Patients With Advanced TumorsAdvanced MalignanciesNCT03995472Jiangsu HengRui Medicine Co., Ltd.14