Study of JS004 Combined With Toripalimab for Advanced Lung Cancer
- Conditions
- Advanced Lung Cancer
- Interventions
- Drug: JS004 in combination with toripalimab
- Registration Number
- NCT05000684
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
Not provided
- 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；
- Have a history of psychotropic drug abuse and unable to withdraw or have mental disorders;
- Pregnant or lactating woman;
- Known to be allergic to JS004 or toripalimab and its components;
- Other severe, acute or chronic medical or psychiatric disorders or laboratory abnormalities that, in the investigator's opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results；
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description JS004 200 mg in combination with toripalimab 240 mg was administered every 3 weeks as planned JS004 in combination with toripalimab -
- Primary Outcome Measures
Name Time Method 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 PFS 2 years Progression-free survival
DOR 2 years Duration of Response
Tmax 2 years Time to Cmax
Kel 2 years Elimination rate constant
Rac 2 years Accumulation factor
OS 2 years Duration of Response
Cmax 2 years Maximum Plasma Concentration
DCR 2 years Disease Control Rate
t1/2 2 years Elimination half life time
CL/F 2 years Clearance
AUC0-t 2 years Area under the concentration versus time curve from time 0 to the last measurable concentration
AUC0-inf 2 years AUC from time 0 to infinity
Vd/F 2 years Apparent volume of distribution
Trial Locations
- Locations (2)
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
Cancer Hospital of Chinese Academy of Medical Sciences
🇨🇳Beijing, China