Clinical Study of JS201 in Patients With Advanced Malignant Tumors

  • STATUS
    Recruiting
  • End date
    Jul 7, 2023
  • participants needed
    174
  • sponsor
    Shanghai Junshi Bioscience Co., Ltd.
Updated on 15 August 2021

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.

Details
Condition Patients With Advanced Malignant Tumors
Treatment JS201
Clinical Study IdentifierNCT04956926
SponsorShanghai Junshi Bioscience Co., Ltd.
Last Modified on15 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Known allergy to any component of JS201
Having received the treatment targeting TGF- or TGF-receptor previously
Not receiving other investigational product within 4 weeks prior to the first dose of JS201
Major surgery or in the recovery period of the surgery within 4 weeks prior to the first dose of JS201
Antitumor chemotherapy, radiotherapy, hormone therapy, targeted therapy, immunotherapy or biotherapy within 4 weeks prior to the first dose of JS201
Use of immunosuppressive drug or immunostimulants within two weeks prior to the first dose of JS201
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
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)
Symptomatic central nervous system (CNS) metastasis requiring intervention (including corticosteroids and antiepileptics)
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
Active infection requiring systematic treatment/antibiotics or intravenous use of systemic anti-infection therapy with one week prior to the first dose
History of concurrent serious cerebro- and cardiovascular diseases
Presence of active tuberculosis, or interstitial lung disease requiring oral or intravenous steroids or history of pneumonia
Known positive for human immunodeficiency virus (HIV)
Having evidence on infection of hepatitis B virus (HBV) or hepatitis C virus (HCV)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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