A Phase I/II, Open-label, Multi-center Trial to Investigate the Efficacy and Safety of SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country30 target enrollmentSeptember 2021

ConditionsNasopharyngeal Carcinoma

InterventionsSHR-1701 Famitinib

DrugsSHR-1701 Famitinib

Overview

Phase: Phase 1
Intervention: SHR-1701
Conditions: Nasopharyngeal Carcinoma
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 30
Locations: 1
Primary Endpoint: ORR
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open label, multi-center, phase I/II study to evaluate the efficacy and safety of SHR-1701 in combination with famitinib in subjects with recurrent/metastatic nasopharyngeal carcinoma(R/M NPC).

Registry

clinicaltrials.gov

Start Date

September 2021

End Date

February 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed Recurrent/Metastatic Nasopharyngeal Carcinoma
•Subjects failure after platinum-based chemotherapy and anti-PD-1/PD-L1 antibody therapy;
•Able and willing to provide signed informed consent form, and able to comply with all procedures.
•Life expectancy \>= 12 weeks as judged by the Investigator.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry.
•Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
•Adequate hematological, hepatic and renal function as defined in the protocol Other protocol-defined inclusion criteria could apply

Exclusion Criteria

•Anticancer treatment within 28 days before the first dose of study drug.
•Major surgery within 28 days before start of trial treatment.
•Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment.
•With any active autoimmune disease or history of autoimmune disease.
•With active central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention.
•History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy.
•Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 2 years. Subjects with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded.

Arms & Interventions

SHR-1701 plus Famitinib

SHR-1701+Famitinib for R/M NPC failure after platinum-based chemotherapy and anti PD-1/PD-L1 antibody therapy

Intervention: SHR-1701

SHR-1701 plus Famitinib

SHR-1701+Famitinib for R/M NPC failure after platinum-based chemotherapy and anti PD-1/PD-L1 antibody therapy

Intervention: Famitinib

Outcomes

Primary Outcomes

ORR

Time Frame: up to approximately 2 years (anticipated)

ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1.