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

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Xiaoyao Tian, MD; Phone Number: 13514257836; Email: xiaoyao_tian@junshipharma.com

Study Locations

• China
  • Beijing, China, 100029
    • Not yet recruiting
    • Cancer Hospital of Chinese Academy of Medical Sciences
    • Contact: Jie Wang, MD; Phone Number: 13910704699; Email: zlhuxi@163.com
  • Jilin
    • Changchun, Jilin, China, 130012
      • Recruiting
      • Jilin Cancer Hospital
      • Contact: Ying Cheng, Doctor; Phone Number: +8643180596067; Email: jl.cheng@163.com

Participation Criteria

Eligibility Criteria

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

Description

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."

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: Inject 200mg once every 3 weeks

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 (Anticipated): August 30, 2023
• Study Completion (Anticipated): August 30, 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): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; 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