A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HDM2017 Combination Therapy in Participants With Advanced Colorectal Cancer
This is a multicenter, open-label, dose-escalation/dose-expansion, Phase Ib/II study to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor efficacy of HDM2017 combination therapy in participants with advanced CRC. The study is divided into two periods: dose escalation (Phase Ib) and dose expansion (Phase II). Phase Ib of this study is a dose-finding study of different HDM2017 combination therapies. The Phase II study will be conducted at a dose determined to be safe and potentially effective in Phase Ib.
• Participants must voluntarily participate in this study and sign the written ICF after being fully informed.
• Male or female participants aged 18 to 75 years (inclusive).
• Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic CRC.
• Able to provide fresh or archived tumor tissue samples during the screening period.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
• Life expectancy ≥ 3 months.
• Participants must have at least one measurable lesion according to RECIST v1.1.
• Laboratory test results at the screening period must indicate that the participant has adequate organ function.
• Women of childbearing potential (WOCBP) must agree to use a reasonable method of contraception from the time of signing the ICF until 7 months after the last dose; and must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before the first dose. Male participants must agree to use adequate contraception from the first dose until 7 months after the last dose.
⁃ Participants must be willing and able to complete regular visits, treatment plans, laboratory tests, and other study procedures.