Squamous Cell Carcinoma of Head and Neck
Conditions
Keywords
SHR-1701, Phase II
Brief summary
This is an open label, single-arm, multi-center, phase II study of SHR-1701 in patients with recurrent/metastatic SCCHN
Interventions
DRUGSHR-1701
Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2 cohorts
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed Recurrent/Metastatic SCCHN,not include NPC 2. Subjects failure after 1 lines of platinum based chemotherapy or failure from anti-PD-1/PD-L1 antibody therapy. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry. 4. Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 5. Adequate hematological, hepatic and renal function as defined in the protocol Other protocol-defined inclusion criteria could apply.
Exclusion criteria
1. Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor. 2. Anticancer treatment within 28 days before the first dose of study drug. 3. Major surgery within 28 days before start of trial treatment. 4. 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. 5. With any active autoimmune disease or history of autoimmune disease. 6. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) per RECIST 1.1 | up to 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DOR | 24 months | Duration of response |
| DCR | 24 months | Disease Control Rate |
| PFS | 24 months | Progression free survival |
| OS | 24 months | Overall Survival |
| AEs | 24 months | Incidence and severity of adverse events |
Countries
China
Contacts
Primary ContactYuankai Shi
Backup ContactQing Yang
Outcome results
None listed