Study Results
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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COMPLETED
PHASE1
42 participants
INTERVENTIONAL
2018-08-13
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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10 mg/kg Q2W
10 mg/kg IV every 2 weeks
10 mg/kg Q2W
10 mg/kg MSB2311 every two weeks
20 mg/kg Q3W
20 mg/kg IV every 3weeks
20 mg/kg Q3W
20 mg/kg MSB2311 every three weeks.
Interventions
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10 mg/kg Q2W
10 mg/kg MSB2311 every two weeks
20 mg/kg Q3W
20 mg/kg MSB2311 every three weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* There is a histologically or cytologically confirmed, locally advanced or metastatic tumor that is not resectable
* b period participants shall provide the archive paraffin embedding tumor tissue samples
* The eastern United States cooperative tumor group (ECOG) score was 0 or 1
* Expect to survive at least 3 months
* Subjects must have measurable lesions (at least 1 lesion) and minimum tumor-specific antigen levels where applicable
* If you have received antitumor therapy, you need to meet certain conditions
* There are suitable organs and hematopoietic functions
* Male subjects and female subjects of child-bearing age shall agree to take effective, investigator-approved contraceptive measures from the date of signing the informed consent until 3 months after the last administration
Exclusion Criteria
* Adverse reactions to previous treatments did not return to CTCAE v4.03 rating ≤ 1, except for residual alopecia effect
* Patients who had been treated with anti-pd-1 or pd-l1 antibodies, or who had been treated with antibodies/drugs that target any other t-cell co-regulatory proteins within 12 weeks of the first administration of the drug in this study
* Patients with primary CNS tumors or CNS metastases known or identified during screening
* Subjects with active or pre-existing autoimmune disease that may recur or patients at high risk
* Patients who had major surgery in the first 4 weeks of screening and who were expected to have major surgery during the study period including a 28-day screening period
* Subjects who require systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to enrollment or during the study period
* Sudden pulmonary disease, interstitial pulmonary disease or pneumonia, or other uncontrolled systemic disease, including diabetes, pulmonary fibrosis, acute pulmonary disease, cardiovascular disease, including hypertension, except local interstitial pneumonia induced by radiotherapy
* A history of human immunodeficiency virus infection, or other acquired or congenital immunodeficiency, or a history of organ transplantation, or stem cell transplantation
* Had a history of tuberculosis, or had tuberculosis disease at the time of screening
* Patients with chronic hepatitis b or active hepatitis c.Hepatitis b carriers, stable hepatitis b after drug treatment and cured hepatitis c patients can be included in the group
* Patients who have been seriously infected within 4 weeks prior to first administration, or who have developed signs or symptoms of any active infection within the previous 2 weeks, or who require antibiotic treatment within the previous 2 weeks;Unexplained fever occurred before the first administration and the body temperature exceeded 38.5℃
* Subjects who have previously been known to have a severe allergic reaction to a macromolecular protein preparation/monoclonal antibody or to any component of the test drug
* Immune-related adverse events (irAE) grade ≥3 occurred after receiving immunotherapy
* Participated in clinical trials of other drugs within 4 weeks before enrollment
* A history of alcohol, drug or substance abuse within the last 1 year
* Has a clear history of neurological or psychiatric disorders, such as epilepsy, dementia, poor compliance
* A woman who is pregnant or breastfeeding
18 Years
75 Years
ALL
No
Sponsors
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Suzhou Transcenta Therapeutics Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Mengde Wang
Role: STUDY_DIRECTOR
Suzhou Transcenta Therapeutics Co., Ltd.
Locations
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Mabspace Biosciences (Suzhou) Co., Ltd.
Suzhou, Jiangsu, China
Countries
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Other Identifiers
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MSB2311-CSP-002
Identifier Type: -
Identifier Source: org_study_id