NCT04856774CompletedPhase 1
A Multicenter, Open-Label, Phase Ib/II Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.1 site in 1 country81 target enrollmentStarted: June 1, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
SHR -1701 + BP102
Experimental
Intervention: SHR-1701；BP102 (Drug)
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: 2 years
recommended phase 2 dose (Phase Ib)
Time Frame: At the end of Cycle 2 (each cycle is 21 days)
Secondary Outcomes
- 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)
- ORR(2 years)
- Progression-free survival (PFS)(2 years)
- Overall survival (OS)(2 years)
Investigators
Study Sites (1)
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