Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
NCT ID: NCT04856774
Last Updated: 2024-06-27
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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COMPLETED
PHASE1/PHASE2
81 participants
INTERVENTIONAL
2021-06-01
2024-03-30
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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SHR -1701 + BP102
SHR-1701；BP102
Drug: SHR-1701 IV infusion
Drug: BP102 IV infusion
Phase Ib: SHR-1701 30mg/kg + BP102 15mg/kg Q3w as starting dose, until recommended phase 2 dose is determined.
Interventions
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SHR-1701；BP102
Drug: SHR-1701 IV infusion
Drug: BP102 IV infusion
Phase Ib: SHR-1701 30mg/kg + BP102 15mg/kg Q3w as starting dose, until recommended phase 2 dose is determined.
Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically confirmed metastatic or locally advanced solid tumors of the selected indications. (Phase II).
3. .Life expectancy exceeds 12 weeeks;
4. The Eastern Cancer Cooperative Group (ECOG) has a performance score of 0 or 1;
5. Normal organ and marrow function;
Exclusion Criteria
2. A history of human immunodeficiency virus (HIV) infection is known, or has an active autoimmune disease.
3. History of interstitial lung disease or pneumonia requiring oral or intravenous steroids.
4. Has moderate or severe cardiovascular disease;
5. Active HBV(hepatitis B) or HCV (Hepatitis C virus)-infected subjects;
6. Any other malignancies within 5 years except for those with negligible risk of metastasis or death.
18 Years
75 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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Sun Yat-sen University Cancer Center
Guangzhou, Guangzhou, China
Countries
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Other Identifiers
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SHR-1701-II-207
Identifier Type: -
Identifier Source: org_study_id
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