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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04346381
• Other study ID #: SHR-1210-II-215
• Status: Completed
• Phase: Phase 2
• Start date: June 5, 2020
• Est. completion date: June 22, 2022

Study information

• Verified date: September 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: June 22, 2022
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• Camrelizumab
Intravenous (IV) camrelizumab on Day 1 of each cycle
• Famitinib
famitinib po qd

Locations

Country	Name	City	State
China	Fudan University Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	Response Rate	Up to 18 months
Secondary	PFS	Progression-free Survival	Up to 18 months
Secondary	DOR	Duration of Response	Up to 18months
Secondary	DCR	Disease Control Rate	Up to 18months
Secondary	TTR	Time to Response	Up to 18 months
Secondary	OS	overall survival rate	Up to 18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Serum concentration of camrelizumab	Serum concentration of camrelizumab	Up to 18 months
Secondary	Plasma concentration of famitinib	Plasma concentration of famitinib	Up to 18 months