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

Conditions

Solid Tumor

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.

Luoyan Ai, Qian Li, Shilong Zhang, Yu Dong, Mudan Yang et al. (22 authors)

The Innovation2025-01-01

10.1016/j.xinn.2024.100745

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Shengxiang Ren, Anwen Xiong, Jia Yu, Xicheng Wang, Baohui Han et al. (24 authors)

Cancer Immunology Immunotherapy2024-05-104 citations

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First-line treatment with camrelizumab plus famitinib in advanced or metastatic NSCLC patients with PD-L1 TPS ≥1%: results from a multicenter, open-label, phase 2 trial

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Camrelizumab plus famitinib in patients with recurrent or metastatic nasopharyngeal carcinoma treated with PD-1 blockade: data from a multicohort phase 2 study.

Ding X, Hua YJ, Zou X, Chen XZ, Zhang XM, Xu B, Ouyang YF, Tu ZW, Li HF, Duan CY, Zhang WJ, You R, Liu YP, Liu YL, Yang Q, Huang PY, Wang SN, Fan J, Chen MY.

2023-06-2310 citations

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Camrelizumab plus famitinib in patients with metastatic colorectal cancer: Results from an open-label, multicenter phase II basket study.

Tianshu Liu, Mudan Yang, Jin Li, Yueyin Pan, Ying Yuan et al. (18 authors)

Journal of Clinical Oncology2022-06-01

10.1200/jco.2022.40.16_suppl.3577

Camrelizumab plus famitinib in patients with recurrent or metastatic nasopharyngeal carcinoma: Data from an open-label, multicenter phase II basket study.

Ming‐Yuan Chen, Xiaozhong Chen, Ximei Zhang, Tianshu Liu, Xicheng Wang et al. (9 authors)

Journal of Clinical Oncology2022-06-01

10.1200/jco.2022.40.16_suppl.e18031

Interventions

DRUGCamrelizumab

Intravenous (IV) camrelizumab on Day 1 of each cycle

DRUGFamitinib

famitinib po qd

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
Response Rate	Up to 18 months	Response Rate

Secondary

Measure	Time frame	Description
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
PFS	Up to 18 months	Progression-free Survival
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.
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
Serum concentration of camrelizumab	Up to 18 months	Serum concentration of camrelizumab
Plasma concentration of famitinib	Up to 18 months	Plasma concentration of famitinib
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

Countries

China

Outcome results

None listed