A Trial of the Combination of SHR-A1811 and Fluzoparib in HER2-Expressing Cancers
NCT ID: NCT05349409
Last Updated: 2022-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
212 participants
INTERVENTIONAL
2022-06-09
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment group
SHR-A1811, Fluzoparib
SHR-A1811
SHR-A1811 for Injection: Given IV.
Fluzoparib Capsule
Fluzoparib Capsule: Given PO.
Interventions
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SHR-A1811
SHR-A1811 for Injection: Given IV.
Fluzoparib Capsule
Fluzoparib Capsule: Given PO.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. At least one measurable lesion that meets RECIST 1.1 criteria in case of solid tumors.
3. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
4. Life expectancy ≥12 weeks.
5. Adequate organ functions as defined.
6. Swallow the drug pills normally.
Exclusion Criteria
2. Cancerous ascites and pleural effusion with clinical symptoms, which need puncture and drainage.
3. Prior malignancy (other than current malignant tumor) within 5 years before the first dose of study treatment.
4. History of autoimmune diseases.
5. Not well controllable and serve cardiovascular disease.
6. Prior lung disease with clinical significance.
7. Occurrence of ≥ grade 2 of bleeding event within 4 weeks before the first dose, or currently receiving the anticoagulation.
8. Active Hepatitis B and Hepatitis C; or serve infection with medication control.
9. The grade of toxicity from the prior anti-cancer therapy not decrease to ≤ 1.
10. Occurrence of intestinal obstruction and gastrointestinal perforation within 3 months before the first dose.
18 Years
ALL
No
Sponsors
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Suzhou Suncadia Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Countries
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Other Identifiers
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SHR-A1811-Ⅱ-201
Identifier Type: -
Identifier Source: org_study_id
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