Status:
COMPLETED
Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
Lead Sponsor:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The main purpose of this study was to assess the safety, tolerability, and efficacy when combining SHR-1701 and BP102 in participants with certain cancers. This study was conducted in 2 phases, Phase ...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable for which standard curative or palliative measures do not exist or are no longer effective (phase Ib)
- Histologically or cytologically confirmed metastatic or locally advanced solid tumors of the selected indications. (Phase II).
- .Life expectancy exceeds 12 weeeks;
- The Eastern Cancer Cooperative Group (ECOG) has a performance score of 0 or 1;
- Normal organ and marrow function;
Exclusion
- Has known active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable.
- A history of human immunodeficiency virus (HIV) infection is known, or has an active autoimmune disease.
- History of interstitial lung disease or pneumonia requiring oral or intravenous steroids.
- Has moderate or severe cardiovascular disease;
- Active HBV(hepatitis B) or HCV (Hepatitis C virus)-infected subjects;
- Any other malignancies within 5 years except for those with negligible risk of metastasis or death.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2024
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT04856774
Start Date
June 1 2021
End Date
March 30 2024
Last Update
June 27 2024
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangzhou, China, 510060