SHR-1701 in Patients With Recurrent/Metastatic Scchn

Sponsor

Jiangsu HengRui Medicine Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04650633

Collaborator

(none)

130

Enrollment

Location

Arm

19.8

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Squamous Cell Carcinoma of Head and Neck	Drug: SHR-1701	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

2 cohorts2 cohorts

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 7, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: SHR-1701

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

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tumor Hospital of the Chinese Academy of Medical Sciences	Beijing		China

Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiangsu HengRui Medicine Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04650633

Other Study ID Numbers:

SHR-1701-II-208

First Posted:

Dec 2, 2020

Last Update Posted:

Oct 29, 2021

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.

SHR-1701

Phase II

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Study Results

No Results Posted as of Oct 29, 2021