Last updated: October 28, 2021
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Active - Recruiting
Phase
2
Condition
Carcinoma
Head And Neck Cancer
Lung Cancer
Treatment
N/AClinical Study ID
NCT04650633
SHR-1701-II-208
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologically confirmed Recurrent/Metastatic SCCHN,not include NPC
- Subjects failure after 1 lines of platinum based chemotherapy or failure fromanti-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 byResponse Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Adequate hematological, hepatic and renal function as defined in the protocol Otherprotocol-defined inclusion criteria could apply.
Exclusion
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 doseof study drug; or use any investigational drug within 28 days before the start oftrial 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 systemicviral infection requiring therapy.
Study Design
Total Participants: 130
Study Start date:
May 07, 2021
Estimated Completion Date:
January 31, 2023
Connect with a study center
Tumor Hospital of the Chinese Academy of Medical Sciences
Beijing,
ChinaActive - Recruiting
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