Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors

Launched by INNOVENT BIOPHARMACEUTICAL TECHNOLOGY (HANGZHOU) CO., LTD. · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial, called the Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors, is designed to test a new treatment called IBI3020. The main goals are to see how safe IBI3020 is, how well people can tolerate it, and to find the highest dose that can be given without causing serious side effects. The trial is currently looking for participants who are 18 years or older and have certain types of solid tumors that cannot be surgically removed and have not responded well to standard treatments.

To be eligible for this study, participants must have a measurable tumor, be in relatively good health (with a specific performance status), and have a life expectancy of at least 12 weeks. They should not have had certain prior treatments or health conditions that could interfere with the trial. If someone joins the study, they will receive IBI3020 and be closely monitored for any side effects or changes in their condition. It’s important for potential participants to understand all the details and requirements before deciding to take part in this research.

Gender

ALL

Eligibility criteria

• 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.