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Study to Evaluate the Efficacy and Safety of Camrelizumab and Famitinib in Patients With Advanced Solid Tumor

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04346381
Collaborator
(none)
286
Enrollment
1
Location
1
Arm
26.2
Anticipated Duration (Months)
10.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, multi-center study to evaluate the anti-tumor activity and safety of camrelizumab combined famitinib in subjects with selected advanced solid tumor.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
286 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Multi-center，Phase II Study of Camrelizumab Combined With Famitinib in the Treatment of Advanced Solid Tumor
Actual Study Start Date :
Jun 5, 2020
Anticipated Primary Completion Date :
Aug 11, 2022
Anticipated Study Completion Date :
Aug 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: camrelizumab combined with famitinib

Participants will receive camrelizumab on Day 1of each cycle and famitinib qd up to 2 years.

Drug: Camrelizumab
Intravenous (IV) camrelizumab on Day 1 of each cycle
Other Names:
  • SHR-1210

    • Drug: Famitinib
    famitinib po qd

    Outcome Measures

    Primary Outcome Measures

    1. Response Rate [Up to 18 months]

      Response Rate

    Secondary Outcome Measures

    1. PFS [Up to 18 months]

      Progression-free Survival

    2. DOR [Up to 18months]

      Duration of Response

    3. DCR [Up to 18months]

      Disease Control Rate

    4. TTR [Up to 18 months]

      Time to Response

    5. OS [Up to 18 months]

      overall survival rate

    6. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 [Up to 18 months]

      The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 (SAEs) as assessed by CTCAE v5.0

    7. Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities. [Up to 18 months]

      Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.

    8. Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline [Up to 18 months]

      Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline

    9. Serum concentration of camrelizumab [Up to 18 months]

      Serum concentration of camrelizumab

    10. Plasma concentration of famitinib [Up to 18 months]

      Plasma concentration of famitinib

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Histologically- or cytologically-confirmed diagnosis of advanced solid tumor.

    2. Willing to provide tumor tissue for PD-L1 biomarker analysis.

    3. At least one measurable lesion according to RECIST 1.1.

    4. ECOG performance status of 0 to 1.

    5. Life expectancy of more than 12 weeks.

    6. Signing the informed consent forms.

    7. Adequate bone marrow, liver and renal function.

    Exclusion Criteria:

    1. Subjects with untreated central nervous system (CNS) metastases.

    2. Subjects with an active, known or suspected autoimmune disease.

    3. Subjects with clinically significant cardiovascular and cerebrovascular diseases.

    4. Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.

    5. Subjects with previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.

    6. Subjects with arterial / venous thrombosis events occurred within 6 months of the first dose.

    7. Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fudan University Zhongshan Hospital Shanghai Shanghai China

    Sponsors and Collaborators

    • Jiangsu HengRui Medicine Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jiangsu HengRui Medicine Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT04346381
    Other Study ID Numbers:
    • SHR-1210-II-215
    First Posted:
    Apr 15, 2020
    Last Update Posted:
    Feb 10, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Feb 10, 2022