NCT06963281PHASE1Recruiting
Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Start Date
4/29/2025
Completion Date
3/31/2028
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
Age Range: 18 years to 75 years
Inclusion Criteria:
Participants must satisfy all of the following criteria to be enrolled into the study:
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:
Participants who meet any of the following criteria will be disqualified from entering the study:
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.
Interventions
DRUG
IBI3020
Conditions
Solid Tumors
Locations
Mayo Clinic - Arizona
Pheonix, Arizona 85054
United States
Mayo Clinic - Florida
Jacksonville, Florida 32224
United States
Mayo Clinic - Rochester
Rochester, Minnesota 55905
United States
Montefiore Cancer Center
New York, New York 10461
United States
NEXT Houston
Houston, Texas 77054
United States
NEXT Dallas
Irving, Texas 75039
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