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

Phase 1

Completed

• Conditions: Head and Neck Squamous Cell Carcinom; Nasopharyngeal Carcinoma
• Interventions: Biological: JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion; Biological: JS001 and JS004

• Registration Number: NCT04929080
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-10
• Study Start: 2021-05-11
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-18
• Primary Completion: 2023-03-06
• Study Completion: 2023-03-06
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JS004 200mg, Q3W until to 2 years	JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion	Part A: phase I: 3-6; phase II: 66.
JS004 600mg, Q3W until to 2 years	JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion	Part A: phase I: 3-6; phase II: 66.
240mg JS001+100mg JS004, Q3W until to 2 years	JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion	Part B: phase I: 6; phase II: 68.
240mg JS001+200mg JS004, Q3W until to 2 years	JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion	Part B: phase I: 6; phase II: 68.
240mg JS001+100mg JS004, Q3W until to 2 years	JS001 and JS004	Part B: phase I: 6; phase II: 68.
240mg JS001+200mg JS004, Q3W until to 2 years	JS001 and JS004	Part B: phase I: 6; phase II: 68.

Primary Outcome Measures

Name	Time	Method
ORR evaluated according to RECIST 1.1	2 years	Objective Response Rate(ORR) evaluated according to RECIST 1.1
The incidence of adverse events (AE) and serious adverse events (SAE) were assessed	2 years	Incidence and severity of adverse events (AE) and serious adverse events (SAE) as assessed according to NCI-CTCAE 5.0, as well as abnormalities in vital signs, electrocardiogram, and laboratory tests

Secondary Outcome Measures

Name	Time	Method
OS	2 years	Overall survival
6-month OS rate	6 months	6-month overall survival rate
ADA/Nab rate	2 years	the rate of Anti-drug body (ADA) and neutralizing antibody (Nab)
Phase II Recommended Dose of JS004 (RP2D-A) and JS004 combined with JS001(RP2D-B)	2 years	Phase II Recommended Dose of JS004 (RP2D-A) and JS004 combined with JS001(RP2D-B)
DCR	2 years	Disease Control Rate (DCR)
DOR	2 years	Duration of Response
PFS	2 years	Progression-free survival evaluated according to RECIST 1.1
Cmax	2 years	Maximum Plasma Concentration(Cmax) after injection of JS004

Trial Locations

Locations (1)

Sichuan Cancer Hospital; 🇨🇳 Chengdu, China