A Multicenter, Open Phase IIb Clinical Study to Evaluate the Efficacy and Safety of B1962 (AP505) Injection in the Treatment of Advanced Colorectal Cancer
Patients with distant metastasis or unresectable locally advanced colorectal cancer (CRC) who had previously failed oxaliplatin, irinotecan, fluorouracil-based drugs therapy containing disease progression or intolerable toxic side effects.
| No. | Endpoint / Indicator | Assessment Time |
| 1 | Progression-free survival (PFS), 1-year overall survival (OS) rate, OS, duration of response (DOR), and disease control rate (DCR), assessed according to RECIST version 1.1 | 2026-Feb |
| 2 | Safety evaluation including, but not limited to, adverse events (AEs), vital signs, physical examinations, 12-lead electrocardiograms (ECG), and laboratory test results | 2026-Feb |
| 3 | Pharmacokinetic (PK) parameters including, but not limited to: single-dose PK parameters (AUC₀–t, AUC₀–∞, Cmax, Tmax, etc.); multiple-dose PK parameters (AUCss,0–t, AUCss,0–∞, AUCss,τ, Css,max, Css,min, etc.) | 2026-Feb |
| 4 | Anti-drug antibodies (ADA) | 2026-Feb |
| 5 | Quality of life (QOL) scores | 2026-Feb |
| 6 | Assessment of serum biomarkers related to immune modulation and cytokine release, such as IL-2, IL-4, IL-6, IL-10, IFN-γ, as well as serum VEGF, and evaluation of their correlation with the safety and efficacy of B1962 treatment | 2026-Feb |
| 7 | Assessment of PD-L1 expression in tumor tissue and evaluation of its correlation with treatment efficacy | 2026-Feb |
| 8 | Assessment of immune-related biomarkers including MSS/MSI-H status, pMMR/dMMR immune classification, and tumor mutational burden (TMB), and evaluation of their correlation with treatment efficacy | 2026-Feb |
