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The Safety and Efficacy of Multiple-dose of JS004 in Subject With HNC

NCT04929080 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2023-08-01

No results posted yet for this study

Summary

A phase I/II clinical study of JS004 in subjects with head and neck cancer in China, to evaluate the safety, tolerability, PK, immunogenicity, antitumor activity and biomarkers of JS004, define the RP2D. A cycle is 21 days (3 weeks) which includes JS004 being administered IV Q3W and JS004 combine with JS001 being administered IV Q3W. All patients will be treated until disease progression per RECIST v1.1 and iRECIST, or intolerable toxicity per CTCAE 5.0, withdrawal of consent, or end of the study, whichever occurs first.Disease progression must be confirmed at least 4 weeks but no longer than 8 weeks after initial documentation of progression.

Conditions

  • Head and Neck Squamous Cell Carcinom
  • Nasopharyngeal Carcinoma

Interventions

BIOLOGICAL

JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion

200mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion

BIOLOGICAL

JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion

600mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion

BIOLOGICAL

JS001 and JS004

Part B: 100mg JS004 + 240mg JS001 or 200mg JS004+ 240mg JS001

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-11
Primary Completion
2023-03-06
Completion
2023-03-06

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04929080 on ClinicalTrials.gov