A Phase I Study of IBI325 in Patients With Advanced Solid Tumor
NCT ID: NCT05246995
Last Updated: 2022-02-18
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
60 participants
INTERVENTIONAL
2022-03-23
2023-11-23
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
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IBI325 and Sintilimab combination does-escalation
IBI325+Sintilimab
IBI325 + sintilimab combination does-escalation Patients will receive IBI325 monotherapy on Cycle 1 Day 1 ,and then receive IBI325 and sintilimab combination until progressive disease, intolerability, or other reasons leading to treatment discontinuation
Interventions
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IBI325+Sintilimab
IBI325 + sintilimab combination does-escalation Patients will receive IBI325 monotherapy on Cycle 1 Day 1 ,and then receive IBI325 and sintilimab combination until progressive disease, intolerability, or other reasons leading to treatment discontinuation
Eligibility Criteria
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Inclusion Criteria
2. At least one measurable lesion per RECIST 1.1
3. Male or female subject at least 18 years old and no more than 75 years old.
4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
5. Must have adequate organ function
6. Be able to provide archived or fresh tumor tissues Exclusion
1\. Any anti-tumor treatment with 4 weeks, except anti-CD73 monoclonal antibody. 2. Subjects participating in another interventional clinical study, except for during the survival follow-up phase of the studies.
3\. Unstable central nervous system netastases 4. Known active autoimmune disease or inflammatory disease 5. Known active infectious disease 6. Other uncontrolled systematic disease that may increase the risk of participating the study
18 Years
75 Years
ALL
No
Sponsors
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Shandong Cancer Hospital and Institute
OTHER
Responsible Party
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Jinming Yu
Director of the hospital
Locations
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Shandong Province Cancer Hospital
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIBI325Y001
Identifier Type: -
Identifier Source: org_study_id
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