A Phase I Study Of JS015 in Patients With Advanced Solid Tumors
NCT ID: NCT05770310
Last Updated: 2023-03-15
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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UNKNOWN
PHASE1
114 participants
INTERVENTIONAL
2023-02-01
2025-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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JS015
JS015
Patient receives specific dose of JS015. The administration method of JS015 is intravenous infusion.
Interventions
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JS015
Patient receives specific dose of JS015. The administration method of JS015 is intravenous infusion.
Eligibility Criteria
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Inclusion Criteria
2. Histologically- or cytologically-confirmed advanced solid tumors considered failure to the standard treatment, or with no standard treatment, or not available to standard treatment;
3. At least one measurable lesion according to RECIST 1.1;
4. Life expectancy ≥ 3 months;
5. Eastern Cooperative Oncology Group (ECOG) 0 or 1;
6. Adequate organ function;
7. Treatment related toxicities due to prior anti-cancer therapy including surgery and radiotherapy must be ≤ grade 1;
8. Women of childbearing age must confirm that the serum pregnancy test is negative within 7 days before the first dose; Male and female patients of child bearing potential will to use abstinence or an effective method of contraception throughout the treatment period and for 90 days following the last dose of study drug;
Exclusion Criteria
2. Has a known additional malignancy in the last 5 years.
3. Pregnancy or lactation;
4. History of immunodeficiency, including human immunodeficiency virus(HIV) test positive, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
5. Brain or meningeal metastases
6. Pleural effusion, peritoneal effusion or pericardial effusion that required treatment (such as puncture, drainage)
7. Severe cardiovascular and cerebrovascular diseases;
8. Previous antineoplastic therapy meets washout requirements.
9. Severe infection (Criteria for the evaluation of common adverse events(CTC AE) 5.0\>2 grade) occurred within 28 days before the first study administration; Active infection or unexplained fever \> 38.5°C ;
10. Has active tuberculosis or hepatitis B (HBV) or hepatitis C (HCV);
11. moderate to severe that seriously affect lung function;
12. Other serious physical or mental diseases or laboratory abnormalities, or alcoholism, drug abuse, etc.,
18 Years
75 Years
ALL
No
Sponsors
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Sponsor GmbH
OTHER
Shanghai Junshi Bioscience Co., Ltd.
OTHER
Responsible Party
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Principal Investigators
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Jin Li, Medical Doctor
Role: PRINCIPAL_INVESTIGATOR
Affiliation: Shanghai Oriental Hospital
Jinming Yu, Medical Doctor
Role: PRINCIPAL_INVESTIGATOR
Shandong Cancer Hospital and Institute
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Shandong Cancer Hospital
Jinan, Shandong, China
Shanghai Oriental Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JS015-001-I
Identifier Type: -
Identifier Source: org_study_id
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