Combining JS004 and Toripalimab for advanced solid tumors

A Phase I Clinical Study Evaluating the Safety, Tolerability,of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined Witht Oripalimab in Patients With Advanced Solid Tumors

This study is testing a new combination of two treatments, JS004 and Toripalimab, to see if they can help people with advanced solid tumors who haven't had success with other therapies.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 198 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. (other)
• Drugs / interventions: toripalimab, chemotherapy, immunotherapy
• Locations: 2 sites (Beijing, Beijing and 1 other locations)
• Trial ID: NCT05427396 on ClinicalTrials.gov

What this trial studies

This phase I clinical study evaluates the safety and initial efficacy of a combination treatment using JS004, a humanized anti-BTLA monoclonal antibody, and Toripalimab, an anti-PD-1 antibody, in patients with advanced solid tumors who have not responded to standard therapies. The study is open-label and aims to determine how well these treatments work together in this patient population. Participants will undergo assessments to monitor their response to the treatment and any side effects experienced.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 with advanced solid tumors that have been confirmed histologically or cytologically and who have failed standard therapy.

Not a fit: Patients with other malignancies or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.

How similar studies have performed: While this approach is novel, similar studies combining monoclonal antibodies with immunotherapies have shown promise in other cancer types.

Eligibility criteria

Inclusion Criteria:

1. Sign the informed consent form voluntarily;
2. Patient (both sex) ≥ 18 and ≤70 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. Patients with advanced solid tumors confirmed histologically or cytologically
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;
8. The patient 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 received systemic antitumor therapy (including chemotherapy, small-molecule targeted drug therapy, endocrine therapy, etc.) or local antitumor therapy within 4 weeks prior to 1st administration
3. Received immunotherapy (including antibody and cell therapy) within 4 weeks prior to 1st administration
4. Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past;
5. Central nervous system metastases and/or cancerous meningitis
6. Have or are suspected of having active autoimmune diseases, including but not limited to systemic lupus erythematosus rheumatoid arthritis inflammatory bowel disease autoimmune hepatitis
7. A large amount of hydrothorax or ascites or pericardial effusion with clinical symptoms or requiring symptomatic treatment;
8. Have serious cardiovascular and cerebrovascular diseases, such as poorly controlled hypertension (systolic blood pressure\>140mmHg and/or diastolic pressure\> 90mmHg) or pulmonary arterial hypertension; Unstable angina or had a myocardial infarction in the 6 months prior to study use and had coronary artery bypass grafting or stenting; Chronic heart failure with grade 2 heart function (NYHA); Degree above heart block; Left ventricular ejection fraction (LVEF)\<50%; Cerebrovascular accident (CVA) or transient ischemic attack (TIA) occurred within 6 months prior to medication
9. Pulmonary disease: interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm;
10. A positive result for human immunodeficiency virus (HIV) antibody test;
11. Known active tuberculosis (TB).
12. Live vaccine was administered within 4 weeks prior to 1st administration
13. Major surgical procedures (as defined by the investigator, e.g., open biopsy, severe trauma, etc.) within 4 weeks prior to 1st administration
14. Have a history of psychotropic drug abuse and unable to withdraw or have mental disorders;
15. Pregnant or lactating woman;
16. Known to be allergic to JS004 or toripalimab and its components;
17. 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.

Where this trial is running

Beijing, Beijing and 1 other locations

• Chinese PLA General Hospital — Beijing, Beijing, China (RECRUITING)
• Chongqing University Cancer Hospital — Chongqing, Chongqing, China (RECRUITING)

Study contacts

• Study coordinator: jianming Xu, MD

Conditions: Liver Cancer, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Cervical Cancer, MSI-H Colorectal Cancer