Status:
UNKNOWN
A Trial of the Combination of SHR-A1811 and Fluzoparib in HER2-Expressing Cancers
Lead Sponsor:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 pa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT05349409
Start Date
June 9 2022
End Date
May 31 2025
Last Update
June 30 2022
Active Locations (2)
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1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
2
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 410013