A Trial of the Combination of SHR-A1811 and Fluzoparib in HER2-Expressing Cancers
- Registration Number
- NCT05349409
- Lead Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 212
- 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 1.
- Life expectancy ≥12 weeks.
- Adequate organ functions as defined.
- Swallow the drug pills normally.
- 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 ≤ 1.
- Occurrence of intestinal obstruction and gastrointestinal perforation within 3 months before the first dose.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment group SHR-A1811 SHR-A1811, Fluzoparib Treatment group Fluzoparib Capsule SHR-A1811, Fluzoparib
- Primary Outcome Measures
Name Time Method Dose Limited Toxicity 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 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 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
- Secondary Outcome Measures
Name Time Method ADA the date of first dose up to 90 days after last dose Anti-drug antibody, Immunogenicity of SHR-A1811 for Injection
C3h 3 hour after first dose of Fluzoparib Capsule in C2D1 PK concentration of Fluzoparib Capsule
12 months' survival rate from the date of the first dose up to 12 months Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients
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 Disease control rate, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients
AUC0-t the date of first dose to 30 days after last dose PK parameters of SHR-A1811 for Injection
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 Duration of response, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients
TTR from the date of the first dose to the date of treatment termination, up to 6 months Time to Recovery, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients
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 Progression-free survival, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients
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 Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Cmin the date of first dose to 30 days after last dose PK parameters of SHR-A1811 for Injection
Cmax the date of first dose to 30 days after last dose PK parameters of SHR-A1811 for Injection
NAb the date of first dose up to 90 days after last dose Neutralizing Antibody, Immunogenicity of SHR-A1811 for Injection
OS from the date of the first dose to the date of death for any reason, up to 100 months Overall survival, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients
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 The occurrence rate of dose interruption, dose decrease and dose termination because of study drug related toxicity during the study
Trial Locations
- Locations (2)
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China