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Completed

NCT Number: NCT04346381

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

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.

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Key information

Conditions

Solid Tumor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically- or cytologically-confirmed diagnosis of advanced solid tumor.
  • Willing to provide tumor tissue for PD-L1 biomarker analysis.
  • At least one measurable lesion according to RECIST 1.1.
  • ECOG performance status of 0 to 1.
  • Life expectancy of more than 12 weeks.
  • Signing the informed consent forms.
  • Adequate bone marrow, liver and renal function.

Exclusion criteria

  • Subjects with untreated central nervous system (CNS) metastases.
  • Subjects with an active, known or suspected autoimmune disease.
  • Subjects with clinically significant cardiovascular and cerebrovascular diseases.
  • Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
  • Subjects with previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.
  • Subjects with arterial / venous thrombosis events occurred within 6 months of the first dose.
  • Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.

Treatment and study plan

Camrelizumab

Drug

Intravenous (IV) camrelizumab on Day 1 of each cycle

Other names: SHR-1210

Famitinib

Drug

famitinib po qd

Primary outcomes

  1. Response Rate

    Time frame: Up to 18 months

    Response Rate

Secondary outcomes

  1. PFS

    Time frame: Up to 18 months

    Progression-free Survival

  2. DOR

    Time frame: Up to 18months

    Duration of Response

  3. DCR

    Time frame: Up to 18months

    Disease Control Rate

  4. TTR

    Time frame: Up to 18 months

    Time to Response

  5. OS

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: Up to 18 months

    Serum concentration of camrelizumab

  10. Plasma concentration of famitinib

    Time frame: Up to 18 months

    Plasma concentration of famitinib

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Multi-center，Phase II Study of Camrelizumab Combined With Famitinib in the Treatment of Advanced Solid Tumor

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 15, 2020
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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