Back to resultsStudy of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
Primary Purpose
Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SHR-1701；BP102
Sponsored by
About this trial
This is an interventional treatment trial for Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer.
- Failed with prior systemic treatments.
- Measurable disease, as defined by RECIST v1.1
- The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1
- Life expectancy ≥ 3 months
- Adequate hematologic and end-organ function as defined in the protocol
Exclusion Criteria:
- Histologically or cytologically confirmed mixed SCLC and NSCLC.
- Symptomatic, untreated or active central nervous system metastases.
- Systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment
- With any active autoimmune disease or history of autoimmune disease.
- Inadequately controlled hypertension.
- Tumor infiltration into the great vessels on imaging.
- History of hemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment.
- Uncontrolled tumor-related pain.
- Patients with active hepatitis B or hepatitis C
- Severe infections within 4 weeks prior to initiation of study treatment.
- Active tuberculosis within one year prior to initiation of study treatment.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SHR-1701+BP102
Arm Description
Outcomes
Primary Outcome Measures
Objective response rate (ORR)
Secondary Outcome Measures
Progression free survival (PFS)
Disease control rate (DCR)
Duration of response (DOR)
Overall survival (OS)
Full Information
NCT ID
NCT04974957
First Posted
July 16, 2021
Last Updated
July 16, 2021
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04974957
Brief Title
Study of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
Official Title
A Multicenter, Open-Label, Phase Ib/II Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2021 (Anticipated)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
August 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The main purpose of this study was to assess the safety,efficacy and pharmacokinetic when combining SHR-1701 and BP102 in participants with advanced or metastatic non-squamous non-small cell lung cancer. To explore the immunogenicity of SHR-1701 and the relationship between corresponding biomarkers and therapeutic effect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR-1701+BP102
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SHR-1701；BP102
Intervention Description
Drug: SHR-1701 IV infusion
Drug: BP102 IV infusion
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Time Frame
2 years
Title
Disease control rate (DCR)
Time Frame
2 years
Title
Duration of response (DOR)
Time Frame
2 years
Title
Overall survival (OS)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer.
Failed with prior systemic treatments.
Measurable disease, as defined by RECIST v1.1
The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1
Life expectancy ≥ 3 months
Adequate hematologic and end-organ function as defined in the protocol
Exclusion Criteria:
Histologically or cytologically confirmed mixed SCLC and NSCLC.
Symptomatic, untreated or active central nervous system metastases.
Systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment
With any active autoimmune disease or history of autoimmune disease.
Inadequately controlled hypertension.
Tumor infiltration into the great vessels on imaging.
History of hemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment.
Uncontrolled tumor-related pain.
Patients with active hepatitis B or hepatitis C
Severe infections within 4 weeks prior to initiation of study treatment.
Active tuberculosis within one year prior to initiation of study treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Shen
Phone
+0518-82342973
Email
hao.shen@hengrui.com
First Name & Middle Initial & Last Name or Official Title & Degree
You Li
Phone
13408501487
Email
you.li.yl1@hengrui.com
12. IPD Sharing Statement
Learn more about this trial
Study of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
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