Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
130 participants
INTERVENTIONAL
2021-05-07
2023-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SHR-1701
R/M SCCHN subjects failure after 1 lines of platinum based chemotherapy or after anti PD-1/PD-L1 antibody therapy.
SHR-1701
Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SHR-1701
Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tumor Hospital of the Chinese Academy of Medical Sciences
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yangkai Shi
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHR-1701-II-208
Identifier Type: -
Identifier Source: org_study_id