This is a Phase III, randomized, open-label, active-controlled, multicenter study designed to evaluate the efficacy and safety of Injection TQB2102 compared with investigator's choice of treatment in subjects with Human Epidermal Growth Factor Receptor 2 (HER2) ImmunoHistoChemistry score 3 (IHC3+) advanced colorectal cancer who have failed prior treatment with oxaliplatin, irinotecan, and fluoropyrimidine-based regimens.
The primary endpoint of this study is progression-free survival (PFS) as assessed by an Independent Review Committee (IRC). The key secondary endpoint is overall survival (OS). Other secondary endpoints include investigator-assessed PFS, objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR), safety, and quality of life scores.
Approximately 142 subjects are planned to be enrolled. Eligible subjects will be randomly assigned in a 1:1 ratio to the experimental group or the control group.
The subject voluntarily participates in this study, signs the informed consent form, and has good compliance.
Aged 18 to 75 years old (calculated as of the date of signing the informed consent form).
Subjects with histologically or cytologically confirmed advanced colorectal cancer.
The subject has confirmed HER2 IHC3+ status in tumor tissue, as determined by the central laboratory designated by the sponsor.
Other malignant tumors treated with curative intent via a single surgical procedure, with disease-free survival (DFS) maintained for 5 consecutive years;
A history of cured carcinoma in situ of the cervix, non-melanoma skin cancer, or superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)].
Presence of diseases that affect intravenous injection or venous blood collection, or factors that impair oral drug administration (e.g., dysphagia, chronic diarrhea, intestinal obstruction, etc.).
Failure of adverse reactions from prior treatments to resolve to ≤ Grade 1 per CTCAE v5.0, with the following exceptions: Grade 2 alopecia, Grade 2 peripheral neurotoxicity, Grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, type 1 diabetes mellitus and hypothyroidism stabilized with hormone replacement therapy, and other toxicities judged by the investigator to pose no safety risks.