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

Phase 2

Completed

• Conditions: Solid Tumor
• Interventions: Drug: Camrelizumab; Drug: Famitinib

• Registration Number: NCT04346381
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-15
• Study Start: 2020-06-05
• Primary Completion: 2022-06-22
• Study Completion: 2022-06-22
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
camrelizumab combined with famitinib	Famitinib	Participants will receive camrelizumab on Day 1of each cycle and famitinib qd up to 2 years.
camrelizumab combined with famitinib	Camrelizumab	Participants will receive camrelizumab on Day 1of each cycle and famitinib qd up to 2 years.

Primary Outcome Measures

Name	Time	Method
Response Rate	Up to 18 months	Response Rate

Secondary Outcome Measures

Name	Time	Method
PFS	Up to 18 months	Progression-free Survival
DOR	Up to 18months	Duration of Response
DCR	Up to 18months	Disease Control Rate
TTR	Up to 18 months	Time to Response
OS	Up to 18 months	overall survival rate
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
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.
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
Plasma concentration of famitinib	Up to 18 months	Plasma concentration of famitinib
Serum concentration of camrelizumab	Up to 18 months	Serum concentration of camrelizumab

Trial Locations

Locations (1)

Fudan University Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China