Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors
NCT ID: NCT06963281
Last Updated: 2025-06-06
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
285 participants
INTERVENTIONAL
2025-04-29
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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IBI3020
IBI3020
Recombinant anti-CEACAM5 monoclonal antibody - dual-payload conjugate for injection
Interventions
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IBI3020
Recombinant anti-CEACAM5 monoclonal antibody - dual-payload conjugate for injection
Eligibility Criteria
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Inclusion Criteria
1. Participants have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
2. Male or female participants ≥ 18 years old. For Part 1, age ≥ 18 years and ≤ 75 years;
3. Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumors which have received available standard therapies and have disease progression, or unacceptable toxic effects, or contraindications;
4. At least 1 measurable lesion as defined per RECIST v1.1 within 28 days prior to the first dose of IBI3020;
5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
6. Minimum life expectancy of 12 weeks;
7. Adequate bone marrow and organ function confirmed at screening period;
8. Participants, both male and female, who are not of childbearing potential or who agree to use at least 1 highly effective method of contraception during the study.
Exclusion Criteria
1. Previous treatment with CEACAM5-targeted therapy;
2. Prior anti-cancer therapy within the wash-out period;
3. Received live vaccines within 4 weeks or cancer vaccine within 3 months;
4. Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives;
5. Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI CTCAE v5.0;
6. Known allergies, hypersensitivity, or intolerance to IBI3020 or its excipients;
7. Undergone major surgery within 4 weeks, or who have severe unhealed wounds;
8. Known symptomatic central nervous system (CNS) metastases;
9. Uncontrolled diseases or conditions;
10. History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases;
11. History of thromboembolic event within 6 months;
12. Under neurological, psychiatric or social condition;
13. Women who are pregnant, have positive results in pregnancy test or are lactating;
14. Not eligible to participate in this study at the discretion of the investigator;
15. Participating in any other interventional clinical research.
18 Years
75 Years
ALL
No
Sponsors
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Fortvita Biologics (USA)Inc.
INDUSTRY
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic - Arizona
Pheonix, Arizona, United States
Mayo Clinic - Florida
Jacksonville, Florida, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Montefiore Cancer Center
New York, New York, United States
NEXT Houston
Houston, Texas, United States
NEXT Dallas
Irving, Texas, United States
The sixth affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Shandong Cancer Hospital
Jinan, Shandong, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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"CIBI3020A101"
Identifier Type: -
Identifier Source: org_study_id
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