Clinical Study of JS201 in Patients With Advanced Malignant Tumors

• Status: Recruiting
• Trial end date: 2023-07-07
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, immunogenicity and preliminary efficacy of JS201 in the patients with advanced malignant tumors who have progression after or on the standard of care, or no effective standard therapeutic regimen. This study is divided into three periods: dose-escalation period, dose expansion period, and clinical expansion period.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Criteria

Inclusion Criteria

1. Understanding and voluntarily signing the informed consent form; 2. Male or female, aged 18 to 70 years (inclusive), for the dose-expansion and clinical expansion parts, aged 18 to 75 years (inclusive); 3. Patients with histologically or cytologically confirmed advanced malignant tumors who have progression after or on the standard of care, or have no effective standard therapeutic regimen; 4. ECOG PS score: 0~1; 5. Patients with life expectancy ≥12 weeks; 6. Presence of at least one measurable lesion meeting the requirements in RECIST v1.1 (solid tumors) or 2014 Lugano (lymphoma) evaluation criteria;

7. Agreement on providing fresh biopsied sample before treatment, or archived sample within two years if there is unreasonable risk of biopsy to the patient; 8. Adequate function of vital organs; 9. Female patients at childbearing age, as well as the male patients whose partners are women of childbearing potential, are required to use a medically recognized contraceptive measure (e.g., intrauterine device IUD, contraceptive or condom) during the study and within 3 months after the end of study treatment; the serum HCG test must be negative in the female patients at childbearing age within 7 days prior to enrollment; and the female patients must be not lactating; Exclusion criteria

1. Known allergy to any component of JS201;

2. Having received the treatment targeting TGF-β or TGF-βreceptor previously;

3. Not receiving other investigational product within 4 weeks prior to the first dose of JS201;

4. Major surgery or in the recovery period of the surgery within 4 weeks prior to the first dose of JS201.

5. Antitumor chemotherapy, radiotherapy, hormone therapy, targeted therapy, immunotherapy or biotherapy within 4 weeks prior to the first dose of JS201;

6. Use of immunosuppressive drug or immunostimulants within two weeks prior to the first dose of JS201;

7. Vaccination of live attenuated vaccine within 30 days prior to the first dose of JS201; use of seasonal influenza vaccine free of live virus is allowed;

8. Having other malignant tumor other than the disease investigated within 5 years prior to the first dose of JS201, however, except for the malignant tumors that can be expected to be cured after treatment (including but not limited to sufficiently treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell carcinoma of skin, or ductal carcinoma in situ treated with radical surgery);

9. Symptomatic central nervous system (CNS) metastasis requiring intervention (including corticosteroids and antiepileptics).

10. Active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying drugs, corticosteroids or immunosuppressants) within two years prior to the first dose of JS201.

11. Active infection requiring systematic treatment/antibiotics or intravenous use of systemic anti-infection therapy with one week prior to the first dose;

12. History of concurrent serious cerebro- and cardiovascular diseases;

13. Presence of active tuberculosis, or interstitial lung disease requiring oral or intravenous steroids or history of pneumonia;

14. Known positive for human immunodeficiency virus (HIV);

15. Having evidence on infection of hepatitis B virus (HBV) or hepatitis C virus (HCV);"