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

Study Overview
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Brief Summary
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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.

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

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: Camrelizumab
* Drug: Famitinib


Participation Criteria
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Eligibility Criteria
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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.

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: camrelizumab combined with famitinib<br>Participants will receive camrelizumab on Day 1of each cycle and famitinib qd up to 2 years. | Drug: Camrelizumab<br>* Intravenous (IV) camrelizumab on Day 1 of each cycle<br>* Other names: SHR-1210;Drug: Famitinib<br>* famitinib po qd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | Response Rate | Up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free Survival | Up to 18 months | 
| DOR | Duration of Response | Up to 18months | 
| DCR | Disease Control Rate | Up to 18months | 
| TTR | Time to Response | Up to 18 months | 
| OS | overall survival rate | Up to 18 months | 
| The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 | 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 | Up to 18 months | 
| Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities. | Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities. | Up to 18 months | 
| Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline | Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline | Up to 18 months | 
| Serum concentration of camrelizumab | Serum concentration of camrelizumab | Up to 18 months | 
| Plasma concentration of famitinib | Plasma concentration of famitinib | Up to 18 months |