SHR-1701 in Patients With Recurrent/Metastatic Scchn

Squamous Cell Carcinoma of Head and Neck Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04650633
• Other study ID #: SHR-1701-II-208
• Status: Recruiting
• Phase: Phase 2
• Start date: May 7, 2021
• Est. completion date: January 2023

Study information

• Verified date: November 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Yuankai Shi
• Phone: +86-010-87788268
• Email: syuankaipumc[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• SHR-1701
Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.

Locations

Country	Name	City	State
China	Tumor Hospital of the Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	DOR	Duration of response	24 months
Secondary	DCR	Disease Control Rate	24 months
Secondary	PFS	Progression free survival	24 months
Secondary	OS	Overall Survival	24 months
Secondary	AEs	Incidence and severity of adverse events	24 months