SHR-1701 in Patients With Recurrent/Metastatic Scchn

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/A

Clinical Study ID

NCT04650633
SHR-1701-II-208
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed Recurrent/Metastatic SCCHN,not include NPC
  2. Subjects failure after 1 lines of platinum based chemotherapy or failure fromanti-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 byResponse Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  5. Adequate hematological, hepatic and renal function as defined in the protocol Otherprotocol-defined inclusion criteria could apply.

Exclusion

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 doseof study drug; or use any investigational drug within 28 days before the start oftrial 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 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,
    China

    Active - Recruiting

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