Study of JS004 Combined With Toripalimab for Advanced Lung Cancer

Advanced Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05000684
• Other study ID #: JS004-006-I/II-LC
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 27, 2021
• Est. completion date: August 30, 2024

Study information

• Verified date: August 2021
• Source: Shanghai Junshi Bioscience Co., Ltd.
• Contact: Xiaoyao Tian, MD
• Phone: 13514257836
• Email: xiaoyao_tian[@]junshipharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Sign the informed consent form voluntarily;

2. Patient (both sex) = 18 years at the time of signing informed consent;

3. Expected survival = 3 months;

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

5. Extensive-stage small cell lung cancer (ES-SCLC, according to the Veterans Administration Lung Study Group VALG Staging) or/and locally advanced (stage IIIB/IIIC), metastatic or recurrent (stage IV) non-small cell lung cancer (NSCLC) by pathologically confirmed

6. At least one measurable lesion as a target lesion (RECIST v1.1 criteria);

7. 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;

8. The subject has good organ function as indicated by screening laboratory results

9. 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;

10. Good compliance and cooperated with the follow-up.

Exclusion Criteria:

1. Any malignancy other than the disease under study within the past 5 years, except for malignancies that can be expected to be cured after treatment (including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated surgically with curative intent);

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. Any adverse reactions caused by previous treatments have not recovered to CTCAE v5.0 Grade 1 or below (except alopecia and neurotoxicity, which cannot be recovered due to long-term presence as judged by the investigator);

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. Pulmonary disease: interstitial pneumonia, obstructive pulmonary disease and 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."

Related Conditions & MeSH terms

• Advanced Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• JS004 in combination with toripalimab
Usage and dosage: Inject 200mg once every 3 weeks

Locations

Country	Name	City	State
China	Cancer Hospital of Chinese Academy of Medical Sciences	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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