Clinical Study of JS201 in Patients With Advanced Malignant Tumors

NCT ID: NCT04956926

Last Updated: 2022-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-29

Study Completion Date

2023-07-07

Brief Summary

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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 during the standard of care, or no effective standard therapeutic regimen. This study is divided into three phases: dose-escalation phase, dose expansion phase, and clinical expansion phase.

Detailed Description

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Conditions

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Patients With Advanced Malignant Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JS201

Group Type EXPERIMENTAL

JS201

Intervention Type DRUG

JS201 is administered intravenously Q3W at the corresponding dose.

Interventions

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JS201

JS201 is administered intravenously Q3W at the corresponding dose.

Intervention Type DRUG

Eligibility Criteria

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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. In the clinical expansion stage, patients with advanced cervical cancer, lymphoma, non-small cell lung cancer (NSCLC), gastric cancer, urothelial cancer and other malignant solid tumors diagnosed by histology or cytology were enrolled (the details shown in the full protocol);
5. ECOG PS score: 0\~1;
6. Patients with life expectancy ≥12 weeks;
7. At least one measurable lesion per RECIST v1.1 (solid tumors) or 2014 Lugano (lymphoma) criteria;
8. Agree to provide fresh biopsies prior to first dose, or archived samples within two years if there is unpredictable risk of biopsy to the patient(at least 15 fresh biopsy sections or 11 surgical sections). For patients who cannot provide abovementioned sections of tissue samples due to special conditions, it needs to contact with the medical monitor of the sponsor to confirm whether this inclusion criterion can be exempted;
9. Function of vital organs must meet the followings (no blood transfusion or hematopoietic stimulating factor used within 14 days prior to the first dose

Absolute neutrophil count (ANC) ≥1.5×109/L;

Platelet (PL) ≥100×109/L;

Hemoglobin (Hb) ≥ 9 g/dL;

Total bilirubin (TBIL) ≤1.5 × ULN; if there is hepatic metastasis, total bilirubin ≤2 × ULN; direct bilirubin (dBIL) ≤ 3.0mg/dL in the patients with Gilbert's syndrome;

Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; or ≤5 × ULN in the patients with hepatic metastasis;

Serum creatinine (Cr) ≤1.5 × ULN, or calculated creatinine clearance (using Cockcroft -Gault formula) ≥50 mL/min, or 24-hour urine creatinine clearance ≥ 50 mL/min;

International normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) ≤1.5 × ULN in the patients receiving no anticoagulation therapy;

QTc interval ≤450 ms for man and ≤470 ms for woman, as calculated using Fridericia's formula;
10. Female patients of childbearing potential and male patients with partners of childbearing potential must agree 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 treatment; the serum HCG test must be negative in the female patients with childbearing potential 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. The patients have previously received the TGF-β/TGF-β receptor targeted drugs;
3. Received other investigational product within 4 weeks prior to the first dose of JS201;
4. Accepted major surgery (judged by investigator) or in the recovery period of the surgery within 4 weeks after the first dose of JS201;
5. Antitumor chemotherapy (6 weeks after the last dose of nitrosourea or mitomycin chemotherapy), radiotherapy, hormone therapy, targeted therapy (for small molecular targeted therapy, within 2 weeks prior to the first dose of JS201), immunotherapy (e.g., anti-PD1/PD-L1 and anti-CTLA-4 therapy) or biotherapy (e.g., cell therapy) within 4 weeks prior to the first dose. Local palliative therapy for isolated lesion is acceptable (e.g., local surgery or radiotherapy), if the tumor evaluation is not affected;
6. Use of immunosuppressive drug or immune enhancing drugs (such as thymosin, interferon, interleukin, etc.) within 2 weeks prior to the first dose. However, corticosteroid nasal spray, inhaler or ≤10 mg/day systemic prednisone and equivalent similar products are accepted. Short-term use of systemic corticosteroid therapy with a dose equivalent to prednisone \> 10 mg / day (e.g. for the treatment/prevention of contrast medium allergy) with ≤ 3 days is allowed;
7. Previous allogeneic bone marrow transplantation or solid organ transplantation;
8. Live attenuated vaccine within 30 days prior to the first dose is excluded, and inactivated influenza vaccination is allowed;
9. Having other malignant tumor other than the disease investigated within 5 years prior to the first dose. The malignant tumors, 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, are eligible;
10. Symptomatic central nervous system (CNS) metastasis requiring intervention (including corticosteroids and antiepileptics). Asymptomatic CNS metastasis previously treated with local therapy is eligible. If the patients confirmed CNS metastasis during screening without any symptoms, and no intervention is required per the standard of care, the eligibility should be determined with the medical monitor of the sponsor;
12. Patients have accepted anti PD-1/PD-L1 monoclonal antibody treatment, and immune related adverse events occurred that stop the treatment;
13. Massive pleural effusion, ascites or pericardial effusion with clinical symptoms or requiring symptomatic treatment;
14. Active autoimmune disease requiring systemic therapy (e.g., corticosteroids or immunosuppressants) within 2 years prior to the first dose.

1\) The autoimmune diseases include but not limited to systemic lupus erythematosus, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism and multiple sclerosis;

2\) Patients with leukoderma or childhood asthma that has been completely relieved and does not need any intervention in adulthood can be enrolled;

3\) For the patients combined with rheumatoid arthritis and other joint diseases, Sjogren's syndrome, celiac disease and psoriasis that have been controlled after local therapy, as well as those with positive antinuclear antibody (ANA) and antithyroid antibody, it should be evaluated whether the target organ is involved and systemic treatment is needed, and their enrollment will be determined by investigator;

4\) Replacement therapy (e.g., thyroxine, insulin or physiological dose of corticosteroid for adrenal or pituitary insufficiency) will not be regarded as systemic treatment;

5\) Patients requiring intermittent use of bronchodilators, inhaled corticosteroids or local injection of corticosteroids for chronic obstructive pulmonary disease (COPD) and asthma can be enrolled.

15\. Active infection requiring systematic treatment/antibiotics or intravenous use of systemic anti-infection therapy with 1 week prior to the first dose or use for more than 7 days;

16\. History of concurrent serious cerebro- and cardiovascular diseases: ≥grade 3 symptomatic congestive heart failure in accordance with New York Heart Association (NYHA) cardiac function grading system, poorly controlled hypertension or arrhythmia, unstable angina pectoris, myocardial infarction, cerebrovascular accident or transient ischemic attack within 6 months prior to the first doses, or any other arterial thrombosis or embolic event;

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

18.Hepatitis (nonalcoholic steatohepatitis and alcoholic/drug-related/autoimmune hepatitis) or cirrhosis;

19\. Known positive for human immunodeficiency virus (HIV);

20\. Patients with evidence of active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients with HBcAb positive and/or HBsAg positive in the screening stage, if the patients with HBV DNA copy number \< 1000 CPS/ml or \< 200 IU/ml can be enrolled. HBsAg positive patients must receive antiviral treatment throughout the study period. Patients with positive HCV antibody in the screening stage can be recruited only when the HCV RNA test result is negative;

21\. Any other clinical significant diseases or conditions can effect on the compliance with the protocol (e.g., history of psychosis or drug abuse), the signature of the informed consent form (e.g., drug addiction and drug abuse), or is unsuitable to be involved in this clinical trial, which determined by investigator.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Junshi Bioscience Co., Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beiijng Cancer Hospital

Beijin, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status NOT_YET_RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangong, China

Site Status NOT_YET_RECRUITING

Affiliated Hospital of Hebei University

Baoding, Hebei, China

Site Status RECRUITING

Harbin medical University cancer hospital

Harbin, Heilongjiang, China

Site Status NOT_YET_RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhenzhou, Henan, China

Site Status NOT_YET_RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Techonoly

Wuhan, Hubei, China

Site Status NOT_YET_RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status NOT_YET_RECRUITING

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Site Status NOT_YET_RECRUITING

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Site Status NOT_YET_RECRUITING

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Site Status NOT_YET_RECRUITING

Shandong Tumor Hospital

Jinan, Shandong, China

Site Status NOT_YET_RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

West China Hospital Sichuan University

Chengdu, Sichuan, China

Site Status NOT_YET_RECRUITING

Cancer Hospital of the University of Chinese Academy of Sciences

Hangzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Pan He, Postgraduate

Role: CONTACT

+8615172333540

Facility Contacts

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Ziping Wang, Prof

Role: primary

Ning Xu, Prof

Role: primary

Zhiming Li, Prof

Role: primary

Jundong Li, Prof

Role: primary

Xicheng Wang, Prof

Role: primary

Fangjian Zhou, Prof

Role: primary

Aimin Zang, Prof

Role: primary

Yanqiao Zhang, Prof

Role: primary

Yanqiu Zhao, Prof

Role: primary

Shujun Yang, Prof

Role: primary

Qingxia Fan, Prof

Role: primary

Guiling li, Prof

Role: primary

Hongjian Guo, Prof

Role: primary

Yong Mao, Prof

Role: primary

Yong Liu, Prof

Role: primary

Bin Hu, Prof

Role: primary

Bo Liu, Prof

Role: primary

Peng Zhang, Prof

Role: primary

Role: backup

Jiyan Liu, Prof

Role: primary

Yun Fan, Prof

Role: primary

Li Zhang, Prof

Role: primary

Other Identifiers

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JS201-001-I

Identifier Type: -

Identifier Source: org_study_id

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