Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Open-Label, Phase Ib/II Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: SHR-1701；BP102


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR -1701 + BP102<br> | Drug: SHR-1701；BP102<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recommended phase 2 dose (Phase Ib) |  | At the end of Cycle 2 (each cycle is 21 days) | 
| Objective response rate (ORR) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Duration of response (DOR) |  | 2 years | 
| Disease control rate (DCR) |  | 2 years | 
| Time to response(TTR) |  | 2 years | 
| Progression-free survival (PFS) |  | 2 years | 
| Overall survival (OS) |  | 2 years |