Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
Phase 1
Completed
- Conditions
- Advanced Solid Tumors
- Interventions
- Drug: SHR-1701；BP102
- Registration Number
- NCT04856774
- Lead Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- 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 Ib and Phase II.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SHR -1701 + BP102 SHR-1701；BP102 -
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) 2 years recommended phase 2 dose (Phase Ib) At the end of Cycle 2 (each cycle is 21 days)
- Secondary Outcome Measures
Name Time Method Disease control rate (DCR) 2 years Duration of response (DOR) 2 years Time to response(TTR) 2 years Dose Limiting Toxicity (DLT) (Phase 1b) At the end of Cycle 2 (each cycle is 21 days) Number of participants with treatment emergent adverse events (TEAEs) For each participant, from the first dose till 90 days after the last dose Number of participants with treatment emergent serious adverse events (SAEs) For each participant, from the first dose till 90 days after the last dose Progression-free survival (PFS) 2 years Overall survival (OS) 2 years ORR 2 years
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangzhou, China