A Clinical Study of SHR-4506 Injection in Patients With Malignant Tumors
NCT ID: NCT07068932
Last Updated: 2025-08-26
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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RECRUITING
PHASE1
102 participants
INTERVENTIONAL
2025-07-22
2027-08-31
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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SHR-4506 Group
SHR-4506 Injection
SHR-4506 injection.
Interventions
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SHR-4506 Injection
SHR-4506 injection.
Eligibility Criteria
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Inclusion Criteria
2. ECOG performance status 0-1.
3. Histologically or cytologically confirmed malignant tumor patients who have failed standard therapy, or are intolerant to standard therapy, or have no standard treatment available.
4. Adequate organ function.
5. Voluntary participation in this clinical trial, with full understanding of study procedures and ability to provide written informed consent.
6. Expected survival ≥12 weeks.
7. Patients in the dose-expansion phase must have measurable lesions.
8. Agreement to use contraception from the time of signing the informed consent to at least 60 days after the last dose of the investigational drug.
Exclusion Criteria
2. Confirmed or suspected central nervous system (CNS) tumor involvement.
3. Uncontrolled tumor-related pain.
4. Active autoimmune disease, history of immunodeficiency (including primary or secondary, e.g., HIV infection), or autoimmune disorders requiring systemic therapy.
5. Clinically significant cardiovascular disease history.
6. Known hypersensitivity to any component of the investigational drug.
7. Major surgery or significant trauma within 4 weeks prior to the first dose of the investigational drug; diagnostic or superficial surgery within 7 days before the first dose; or planned major surgery during the study period.
8. Adverse events from prior therapy have not recovered to ≤ CTCAE Grade 1.
9. Severe infection within 4 weeks before the first dose, or active infection within 2 weeks.
10. History of cerebrovascular accident within 6 months before the first dose of the investigational drug.
11. Patients with other active malignancies within 2 years prior to the first dose or concurrent malignancies.
12. Patients with any other condition judged by the investigator that makes the patient unsuitable for participation in the study.
18 Years
ALL
No
Sponsors
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Suzhou Suncadia Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
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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SHR-4506-101
Identifier Type: -
Identifier Source: org_study_id
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