A Phase Ⅰb/Ⅱ Clinical Study on the Dosage Exploration and Efficiency Expansion of SHR-A1811 for Injection in Combination With Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- Dose Limited Toxicity
研究概览
简要总结
The study is being conducted to evaluate safety, tolerability and preliminary efficacy of SHR-A1811 for Injection in combination with Fluzoparib Capsule for HER2-expressing advanced solid tumors of patients. To explore the reasonable dosage of dosage regimen of combination therapy for HER2-expressing advanced malignant tumors of patients.
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
- •Male or female aged ≥18 years at the time of signing the ICF.
- •At least one measurable lesion that meets RECIST 1.1 criteria in case of solid tumors.
- •An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or
- •Life expectancy ≥12 weeks.
- •Adequate organ functions as defined.
- •Swallow the drug pills normally.
排除标准
- •patients with active meningeal metastasis, or brain metastasis without surgical treatment or radiotherapy.
- •Cancerous ascites and pleural effusion with clinical symptoms, which need puncture and drainage.
- •Prior malignancy (other than current malignant tumor) within 5 years before the first dose of study treatment.
- •History of autoimmune diseases.
- •Not well controllable and serve cardiovascular disease.
- •Prior lung disease with clinical significance.
- •Occurrence of ≥ grade 2 of bleeding event within 4 weeks before the first dose, or currently receiving the anticoagulation.
- •Active Hepatitis B and Hepatitis C; or serve infection with medication control.
- •The grade of toxicity from the prior anti-cancer therapy not decrease to ≤
- •Occurrence of intestinal obstruction and gastrointestinal perforation within 3 months before the first dose.
研究组 & 干预措施
Treatment group
SHR-A1811, Fluzoparib
干预措施: SHR-A1811 (Drug)
Treatment group
SHR-A1811, Fluzoparib
干预措施: Fluzoparib Capsule (Drug)
结局指标
主要结局
Dose Limited Toxicity
时间窗: first dose of study medication up to 21 days
Dose Limited Toxicity of SHR-A1811 for Injection in combination with Fluzoparib Capsule in Dose Exploration Period
Recommended phase II dose
时间窗: first dose of study medication up to 21 days
The Recommended phase II dose of SHR-A1811 for Injection in combination with Fluzoparib Capsule in Dose Exploration Period
ORR
时间窗: from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, or initiation of other anti-tumor treatment, whichever occurs first, up to 6 months
Objective Response Rate, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients in indication expansion period
次要结局
- C3h(3 hour after first dose of Fluzoparib Capsule in C2D1)
- 12 months' survival rate(from the date of the first dose up to 12 months)
- DCR(from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, up to 6 months)
- AUC0-t(the date of first dose to 30 days after last dose)
- ADA(the date of first dose up to 90 days after last dose)
- DoR(from the date of the firstly documented tumor response (evaluated based on RECIST v1.1 criteria) to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, up to 6 months)
- TTR(from the date of the first dose to the date of treatment termination, up to 6 months)
- PFS(from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, up to 6 months)
- Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)(from signature completion of ICF to 30 days after the last dose or to the beginning of the new anti-cancer therapy, up to 6 months)
- Cmin(the date of first dose to 30 days after last dose)
- Cmax(the date of first dose to 30 days after last dose)
- NAb(the date of first dose up to 90 days after last dose)
- OS(from the date of the first dose to the date of death for any reason, up to 100 months)
- The occurrence rate of dose titration due to AE related with study medication(from signature completion of ICF to 30 days after the last dose or to the beginning of the new anti-cancer therapy, up to 6 months)