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

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

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.