Clinical trial NCT05000684: Study of JS004 Combined With Toripalimab for Advanced Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Lung Cancer
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria：

1. Sign the informed consent form voluntarily;
2. Age greater than or equal to 18 years old at time of signing informed consent, males and females are included;
3. Expected survival time is greater than or equal to 3 months;
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
5. Pathologically confirmed locally advanced (Stage III B/C), metastatic or recurrent (Stage IV) non-small cell lung cancer (NSCLC);
6. Pathologically confirmed extensive-stage small cell lung cancer (ES-SCLC, according to the Veterans Administration Lung Study Group (VALG) staging system);
7. At least one measurable lesion as a target lesion (RECIST v1.1 criteria);
8. Agree to provide tumor tissue samples (provide fresh biopsy samples before treatment as far as possible，provide archived samples within 2 years for patients who cannot provide fresh biopsy samples before treatment;
9. The subject has good organ function as indicated by screening laboratory results；
10. Males of reproductive potential or females of childbearing potential must use effective contraceptive methods (such as oral contraceptives, intrauterine device or barrier method combined with spermicide) during the trial and continue contraception for 6 months after the end of treatment;
11. Good compliance and cooperated with the follow-up；

Exclusion Criteria:

1. 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);
2. Patients previously treated with anti-BTLA or anti-HVEM antibodies;
3. Patients previously discontinued treatment due to PD-1/PD-L1 inhibitor toxicity;
4. 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);
5. Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past;
6. A large amount of hydrothorax or ascites or pericardial effusion with clinical symptoms or requiring symptomatic treatment;
7. Known history of Lung disorder: history of Interstitial pneumonia/drug-induced interstitial Pneumopathy or pneumonia, symptomatic Bronchospasm;
8. Active infection requiring systemic therapy;
9. A positive result for human immunodeficiency virus (HIV) antibody test;
10. 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；
11. Have a history of psychotropic drug abuse and unable to withdraw or have mental disorders;
12. Pregnant or lactating woman;
13. Known to be allergic to JS004 or toripalimab and its components;
14. 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；

Primary outcomes:
measure: The incidence of adverse events (AE) and serious adverse events (SAE) were assessed
timeFrame: 2 years
Secondary outcomes:
measure: OS
timeFrame: 2 years
measure: DOR
timeFrame: 2 years
measure: DCR
timeFrame: 2 years
measure: PFS
timeFrame: 2 years
measure: Cmax
timeFrame: 2 years
measure: Tmax
timeFrame: 2 years
measure: AUC0-t
timeFrame: 2 years
measure: AUC0-inf
timeFrame: 2 years
measure: Kel
timeFrame: 2 years
measure: t1/2
timeFrame: 2 years
measure: CL/F
timeFrame: 2 years
measure: Vd/F
timeFrame: 2 years
measure: Rac
timeFrame: 2 years
Other outcomes:
Locations:
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Beijing
country: China
facility: Cancer Hospital of Chinese Academy of Medical Sciences
Study officials:
References: