A Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer
NCT ID: NCT07071714
Last Updated: 2025-08-08
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
PHASE2
200 participants
INTERVENTIONAL
2025-07-22
2031-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part A Group
SHR-8068 Injection
SHR-8068 injection.
Adebrelimab Injection
Adebrelimab injection.
Part B Group
SHR-8068 Injection
SHR-8068 injection.
Adebrelimab Injection
Adebrelimab injection.
Bevacizumab Injection
Bevacizumab injection.
Interventions
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SHR-8068 Injection
SHR-8068 injection.
Adebrelimab Injection
Adebrelimab injection.
Bevacizumab Injection
Bevacizumab injection.
Eligibility Criteria
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Inclusion Criteria
2. Male or female ≥ 18 years old and ≤75 years old.
3. ECOG performance status of 0-1.
4. Part A with a life expectancy of ≥2 years. Part B with a life expectancy of ≥12 weeks.
5. Need to provided tumor tissue samples for genetic testing.
Exclusion Criteria
2. Part B: Systemic antitumor therapy was received 4 weeks before the start of the study.
3. Part B: Palliative radiotherapy was completed within 14 days before the first dose.
5. Subjects with known or suspected interstitial pneumonia.
6. Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion.
7. Have poorly controlled or severe cardiovascular disease.
8. Subjects with active hepatitis B or active hepatitis C.
9. A history of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation.
10. The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention.
11. Any other factors that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate as judged by investigators.
18 Years
75 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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The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 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-8068-206
Identifier Type: -
Identifier Source: org_study_id
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