NCT04929080

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

A Phase I/II Clinical Study of JS004, a Recombinant Humanized mAb Specific to B-and T-Lymphocyte Attenuator (BTLA), in Subjects With Head and Neck Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-05-11
• Primary completion: 2023-03-06
• Completion: 2023-03-06
• First posted: 2021-06-18
• Last updated: 2023-08-01

Locations

1 site across 1 country: China