A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab in Patients With Advanced Lung Cancer

Shanghai Junshi Bioscience Co., Ltd.2 sites in 1 country67 target enrollmentAugust 27, 2021

ConditionsAdvanced Lung Cancer

InterventionsJS004 in combination with toripalimab

DrugsJS004 in combination with toripalimab

Overview

Phase: Phase 1
Intervention: JS004 in combination with toripalimab
Conditions: Advanced Lung Cancer
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Enrollment: 67
Locations: 2
Primary Endpoint: The incidence of adverse events (AE) and serious adverse events (SAE) were assessed
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label phase I/II study to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of JS004 injection combined with toripalimab in patients with advanced lung cancer who have failed standard therapy.

Registry

clinicaltrials.gov

Start Date

August 27, 2021

End Date

October 31, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Within 2 years prior to enrollment, had other active neoplasm malignancies except for the study disease, but excluding neoplasm malignancies expected to be cured after treatment (including but not limited to thyroid cancer, carcinoma cervix in situ, basal or squamous cell skin carcinoma, or ductal carcinoma in situ after radical surgery after adequate treatment);
•Patients previously treated with anti-BTLA or anti-HVEM antibodies;
•Patients previously discontinued treatment due to PD-1/PD-L1 inhibitor toxicity;
•Adverse reaction caused by prior treatment that has not recovered to CTCAE Grade 1 and below (except Grade 2 toxicity that is long-lasting, not recoverable, and does not increase safety risk);
•Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past;
•A large amount of hydrothorax or ascites or pericardial effusion with clinical symptoms or requiring symptomatic treatment;
•Known history of Lung disorder: history of Interstitial pneumonia/drug-induced interstitial Pneumopathy or pneumonia, symptomatic Bronchospasm;
•Active infection requiring systemic therapy;
•A positive result for human immunodeficiency virus (HIV) antibody test;
•Known active tuberculosis (TB). For patients with suspicion of active TB should perform the test of chest X-ray, sputum, clinical signs and symptoms to exclude；

Arms & Interventions

JS004 200 mg in combination with toripalimab 240 mg was administered every 3 weeks as planned

Intervention: JS004 in combination with toripalimab

Outcomes

Primary Outcomes

The incidence of adverse events (AE) and serious adverse events (SAE) were assessed

Time Frame: 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