Status:
RECRUITING
Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors
Lead Sponsor:
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Collaborating Sponsors:
Fortvita Biologics (USA)Inc.
Conditions:
Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to evaluate the safety and tolerability of IBI3020 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RP2D) of IBI3020.
Eligibility Criteria
Inclusion
- Participants must satisfy all of the following criteria to be enrolled into the study:
- 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;
- Male or female participants ≥ 18 years old. For Part 1, age ≥ 18 years and ≤ 75 years;
- 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;
- At least 1 measurable lesion as defined per RECIST v1.1 within 28 days prior to the first dose of IBI3020;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
- Minimum life expectancy of 12 weeks;
- Adequate bone marrow and organ function confirmed at screening period;
- 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
- Participants who meet any of the following criteria will be disqualified from entering the study:
- Previous treatment with CEACAM5-targeted therapy;
- Prior anti-cancer therapy within the wash-out period;
- Received live vaccines within 4 weeks or cancer vaccine within 3 months;
- Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives;
- 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;
- Known allergies, hypersensitivity, or intolerance to IBI3020 or its excipients;
- Undergone major surgery within 4 weeks, or who have severe unhealed wounds;
- Known symptomatic central nervous system (CNS) metastases;
- Uncontrolled diseases or conditions;
- History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases;
- History of thromboembolic event within 6 months;
- Under neurological, psychiatric or social condition;
- Women who are pregnant, have positive results in pregnancy test or are lactating;
- Not eligible to participate in this study at the discretion of the investigator;
- Participating in any other interventional clinical research.
Key Trial Info
Start Date :
April 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT06963281
Start Date
April 29 2025
End Date
March 31 2028
Last Update
June 6 2025
Active Locations (9)
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1
Mayo Clinic - Arizona
Pheonix, Arizona, United States, 85054
2
Mayo Clinic - Florida
Jacksonville, Florida, United States, 32224
3
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
4
Montefiore Cancer Center
New York, New York, United States, 10461