SHR-1701 in Patients With Recurrent/Metastatic Scchn

Study Overview
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Brief Summary
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This is an open label, single-arm, multi-center, phase II study of SHR-1701 in patients with recurrent/metastatic SCCHN

Official Title
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A Phase II,Open-label Trial to Investigate the Efficacy and Safety of SHR-1701 in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Conditions
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Squamous Cell Carcinoma of Head and Neck

Intervention / Treatment
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* Drug: SHR-1701


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed Recurrent/Metastatic SCCHN,not include NPC Subjects failure after 1 lines of platinum based chemotherapy or failure from anti-PD-1/PD-L1 antibody therapy. 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: Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor. 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. 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.

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: 2 cohorts
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-1701<br>R/M SCCHN subjects failure after 1 lines of platinum based chemotherapy or after anti PD-1/PD-L1 antibody therapy. | Drug: SHR-1701<br>* Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) per RECIST 1.1 | 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 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DOR | Duration of response | 24 months | 
| DCR | Disease Control Rate | 24 months | 
| PFS | Progression free survival | 24 months | 
| OS | Overall Survival | 24 months | 
| AEs | Incidence and severity of adverse events | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SHR-1701, Phase II