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

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

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Camrelizumab; Drug: Famitinib

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Fudan University Zhongshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: camrelizumab combined with famitinib; Participants will receive camrelizumab on Day 1of each cycle and famitinib qd up to 2 years.	Drug: Camrelizumab; Intravenous (IV) camrelizumab on Day 1 of each cycle; Other Names: SHR-1210; Drug: Famitinib; famitinib po qd

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2020
• Primary Completion (Actual): June 22, 2022
• Study Completion (Actual): June 22, 2022

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-1210-II-215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No