SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: SHR-1701
* Drug: Famitinib


Participation Criteria
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Eligibility Criteria
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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 1.1. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-1701 plus Famitinib<br>SHR-1701+Famitinib for R/M NPC failure after platinum-based chemotherapy and anti PD-1/PD-L1 antibody therapy | Drug: SHR-1701<br>* Intravenous (IV) on Day 1 of each cycle<br>* Other names: SHR-1701 Injection;Drug: Famitinib<br>* Famitinib, po, qd<br>* Other names: SHR-1020;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | 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. | up to approximately 2 years (anticipated) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DoR | Duration of Response per RECIST 1.1 | up to approximately 2 years (anticipated) | 
| DCR | DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1. | up to approximately 2 years (anticipated) | 
| PFS | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first. | up to approximately 2 years (anticipated) | 
| OS | Overall Survival is defined as the time from registration to death due to any cause, or censored at date last known alive. OS will be measured by the Method of Kaplan and Meier. | up to approximately 2 years (anticipated) | 
| AEs | Number of participants with adverse events as assessed by CTCAE v5.0 | up to approximately 2 years (anticipated) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal Carcinoma, SHR-1701, Famitinib