SHR-1701 in Patients With Recurrent/Metastatic Scchn

Phase 2

• Conditions: Squamous Cell Carcinoma of Head and Neck
• Interventions: Drug: SHR-1701

• Registration Number: NCT04650633
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-11-25
• Study First Posted: 2020-12-02
• Study Start: 2021-05-07
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-10-29
• Primary Completion: 2023-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-1701	SHR-1701	R/M SCCHN subjects failure after 1 lines of platinum based chemotherapy or after anti PD-1/PD-L1 antibody therapy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
OS	24 months	Overall Survival
DOR	24 months	Duration of response
DCR	24 months	Disease Control Rate
PFS	24 months	Progression free survival
AEs	24 months	Incidence and severity of adverse events

Trial Locations

Locations (1)

Tumor Hospital of the Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China