Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC

Sponsor
Taizhou Mabtech Pharmaceutical Co.,Ltd
Study ID
NCT04659369
Phase
PHASE1
Status
Terminated

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CMAB819 — DRUG
    for injection only
  • Nivolumab — DRUG
    for injection only

Study Details

The purpose of this study is to compare the pharmacokinetic, safety, immunogenicity and efficacy of CMAB819 and Nivolumab in subjects with recurrent or metastatic head and neck squamous cell carcinoma., after failure of prior platinum-based chemotherapy.

Key Dates

First listed
Dec 9, 2020
Start date
Sep 24, 2020
Status verified
May 2023
Primary completion
Oct 16, 2023
Completion
Oct 16, 2023

Study Design

Enrollment
21 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CMAB819
    CMAB819 480 mg intravenous (IV) solution for Injection every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
  • Active Comparator: Nivolumab
    Nivolumab 480 mg intravenous (IV) solution for injection every 4 weeks until documented disease progression, discontinuation, withdrawal of consent, or the study ends or up to 4 doses in subjects without disease progression, whichever occurs earlier. After completing 4 doses of Nivolumab therapy, administer of CMAB819 480 mg intravenous (IV) solution for injection every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.

Primary Outcome Measure

AUC0-4w,1 [ Time Frame: Day 1 to Day 29 ]

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