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.
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;
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;
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Lead sponsor
Fortvita Biologics (USA)Inc.
Collaborator