NCT06639347招募中1 期
An Open Label, Multicenter, Phase Ib/Il Study to Evaluate the Safety, Tolerability, and Efficacy of SHR A2102 in Combination With Other Anti-cancer Agents in Patients With Advanced Urothelial Carcinoma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Phase II: ORR by investigator assessment
研究概览
简要总结
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with Antitumor Therapy in Advanced Urothelial Carcinoma. To explore the reasonable dosage of SHR-A2102 for Advanced Urothelial Carcinoma.
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
- •Competent to comprehend, sign, and date an informed consent form.
- •Male or female subjects must be age 18 or older.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Subjects must have histologically documented, unresectable locally advanced or
- •Histologically confirmed locally advanced or metastatic urothelial cancer.Phase Ib, subjects must have failed, be intolerant or refused the standard treatment; Phase II, subjects must not have received systemic antitumor therapy for locally advanced unresectable or metastatic urothelial carcinoma.
- •An archival tumor tissue sample or a fresh tissue sample should be provided.
- •Subjects must have measurable disease according to RECIST (version 1.1).
排除标准
- •Subjects with not adequately treated, or uncontrollable , or active CNS metastases.
- •Subjects who have previously received TOPO1-based ADCs.
- •Subjects who have received anti-cancer treatment within 4 weeks prior the first dose of study treatment.
- •Subjects who have received radiotherapy within 14 days , or chest radiotherapy > 30Gy within 6 months prior to the first dose of study drug.
- •Subjects with ongoing clinically significant toxicity associated with prior treatment that has not resolved to ≤ Grade
- •Subjects who have received systemic immunosuppressant treatment within 14 days prior the first dose of study treatment.
- •Subjects who have known or suspected interstitial pneumonitis.
- •Phase Ib: Subjects who have had≥ Grade 3 irAEs during the previous treatment with ICIs.
- •Subjects who have any active, known or suspected autoimmune diseases.
- •Subjects who have moderate or severe ascites with clinical symptoms, or uncontrolled or moderate or above pleural effusion, or pericardial effusion.
- •Subjects who have uncontrolled cardiac diseases or cardiac clinical symptoms.
研究组 & 干预措施
SHR-A2102 + Adebrelimab injection+SHR-8068 injection
Experimental
干预措施: SHR-A2102 (Drug)
SHR-A2102 + Adebrelimab injection+SHR-8068 injection
Experimental
干预措施: Adebrelimab injection (Drug)
SHR-A2102 + Adebrelimab injection+SHR-8068 injection
Experimental
干预措施: SHR-8068 injection (Drug)
结局指标
主要结局
Phase II: ORR by investigator assessment
时间窗: Up to approximately 5 years
Phase I: RP2D of SHR-A2102 combined with Adebrelimab and SHR-8068 in patients with advanced urothelial cancer
时间窗: Up to approximately 5 years
Phase I: Incidence and severity of adverse events
时间窗: Up to approximately 5 years
次要结局
- Phase II: Incidence and severity of adverse events(up to 5 years)
- Phase I: ORR by investigator assessment(Up to approximately 5 years)
- Phase I: PFS by investigator assessment(Up to approximately 5 years)
- Phase I: Pharmacokinetic parameter for serum concentrations of SHR-A2102 and free toxin(Up to approximately 5 years)
- Phase II: DCR by investigator assessment(Up to approximately 5 years)
- Phase I: DCR by investigator assessment(Up to approximately 5 years)
- Phase I: DoR by investigator assessment(Up to approximately 5 years)
- Phase I: OS by investigator assessment(Up to approximately 5 years)
- Phase I: Anti-SHR-A2102 antibody (ADA) and anti-SHR-A2102 neutralizing antibody (NAb)(Up to approximately 5 years)
- Phase II: DoR by investigator assessment(Up to approximately 5 years)
- Phase II: PFS by investigator assessment(Up to approximately 5 years)
- Phase II: OS by investigator assessment(Up to approximately 5 years)
- Phase II: Pharmacokinetic parameter for serum concentrations of SHR-A2102 and free toxin(Up to approximately 5 years)
- Phase II: Anti-SHR-A2102 antibody (ADA) and anti-SHR-A2102 neutralizing antibody (NAb)(Up to approximately 5 years)
研究者
研究点 (1)
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