Study of JS004 Combined With Toripalimab for Advanced Lung Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Lung Cancer
• Intervention / Treatment: Drug: JS004 in combination with toripalimab

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100029
    • Cancer Hospital of Chinese Academy of Medical Sciences
  • Jilin
    • Changchun, Jilin, China, 130012
      • Jilin Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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；

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JS004 200 mg in combination with toripalimab 240 mg was administered every 3 weeks as planned	Drug: JS004 in combination with toripalimab; Usage and dosage: 200mg of JS004 combined with 240mg of JS001 is given every 3 weeks; Other Names: JS004+JS001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of adverse events (AE) and serious adverse events (SAE) were assessed	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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression-free survival	2 years
OS	Duration of Response	2 years
DOR	Duration of Response	2 years
DCR	Disease Control Rate	2 years
Cmax	Maximum Plasma Concentration	2 years
Tmax	Time to Cmax	2 years
AUC0-t	Area under the concentration versus time curve from time 0 to the last measurable concentration	2 years
AUC0-inf	AUC from time 0 to infinity	2 years
Kel	Elimination rate constant	2 years
t1/2	Elimination half life time	2 years
CL/F	Clearance	2 years
Vd/F	Apparent volume of distribution	2 years
Rac	Accumulation factor	2 years

Collaborators and Investigators

• Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2021
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: JS004-006-I/II-LC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No