SHR-1701 in Patients With Recurrent/Metastatic Scchn

Hengrui Medicine

Status and phase: Unknown; Phase 2

Conditions: Squamous Cell Carcinoma of Head and Neck

Treatments: Drug: SHR-1701

Study type: Interventional

Funder types: Industry

Identifiers

NCT04650633

SHR-1701-II-208

Details and patient eligibility

About

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

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

SHR-1701

Experimental group

Description:

R/M SCCHN subjects failure after 1 lines of platinum based chemotherapy or after anti PD-1/PD-L1 antibody therapy.

Treatment:

Drug: SHR-1701