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

Inclusion criteria

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 criteria

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.